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Thermography is not a feasible option to Mammography for breast cancer – asserts FDA

 

Thermography is used for to investigate heat distribution in regions/structures of body, for tumor detection; infrared camera is used for thermograms.

Healthcare providers and women are specifically alarmed by the FDA, not to opt for thermography as a substitute for mammography screening, to diagnose breast cancer.

The FDA has no available data of thermographic devices, to show that the screening tool is effectual for any medical condition, inclusive of early detection of breast cancers and/or other breast disorders. (Courtesy: U.S. Food and Drug Administration)

Professional societies and health agencies, inclusive of the American College of Radiology, the American Cancer Society, the National Cancer Institute, the Centers for Disease Control and Prevention, and the Society for Breast Imaging – abide with FDA for clinical relevance of mammography for breast cancer detection, over thermography.

Mobile units, websites and various health facilities are encouraging the use of thermography as a complete assessment tool for breast cancer, laying claim that it is a replacement for mammography; it has even been claimed that – thermography is feasible for pre-cancerous irregularities, and can identify breast cancer, long before mammography. The FDA negates that – breast compression during mammography will make the cancer cells spread to neighboring regions in the body.

The FDA is greatly worried about health of women, and feels that these misguiding claims about thermography will make women go for it, than mammography; the food and drug administration has put forward suggestions for women, to have regular mammogram per screening guidelines, and advice by healthcare providers.

Additional diagnostic procedures are being sanctioned by the FDA, per suggestions of care providers, for: breast ultrasound, MRI/biopsy, clinical breast examination, mammographic views etc.

The FDA has directed the companies to stop making false claims about thermography machines, and is continually observing the marketing/promotional activities of thermography equipment manufacturers and medical practitioners.

Mammography is feasible incidentally for breast irregularities associated to extramammary disease, than its regulars in breast cancer.

 

Submitted over as an education exhibit at 2009 RSNA annual meeting, contributions in this segment are being made by Mailan M. Cao, MD; Anne C. Hoyt, MD and Lawrence W. Bassett, MD from the Iris Cantor Center for Breast Imaging, Department of Radiology, David Geffen School of Medicine at UCLA, Los Angeles, CA.

The article is available in the online journal of Radiological Society of North America.

Even though mammography is principally utilized for to recognize breast cancer, it is feasible incidentally for breast irregularities associated to extramammary disease.

Cardiovascular disorders, viz. central venous obstruction and congestive heart failure may show as breast edema and venous engorgement (congestion), at mammography.

Morbid arterial calcifications observed at mammography can show out to basal risk factor for hastened atherosclerosis, viz. chronic renal failure.

Connective tissue disorders (rheumatoid arthritis, systemic scleroderma, systemic lupus erythematosus, dermatomyositis-polymyositis) characteristically demonstrate with bilateral axillary lymphadenopathy; stromal calcifications are even visible in ultimate three disease procedures.

Disorders like filariasis and neurofibromatosis type 1 may show up with pathognomonic findings at mammography; but in contrast – amyloidosis, wegener granulomatosis and sarcoidosis show as non-specific breast masses, not easily characterized from breast cancer, and generally call for tissue biopsy for ratification.

Facts about imaging attributes of varied systemic disorders that affect breast will help radiologist in to discriminate systemic disorders from questionable breast lesions, thus ascertain relevant follow-up examination.

Besides, identification of systemic disorders like Cowden syndrome, which is related with an enhanced risk of breast cancer will facilitate the radiologists to suggest proper supervision.

somo•v ABUS system, from U-Systems has been sanctioned by Medical Devices Bureau of Health Canada for ancillary diagnostic approach with mammography.

 

U-Systems – the market leader in automated breast ultrasound technology has been authorized with medical device license by the Medical Devices Bureau of Health Canada, recently, ratified on basis of clinical evidence.

somo•v ABUS system has now become sole ultrasound equipment for breast cancer screening across European Union countries.

The company can now market and sell its registered brand – somo•v® Automated Breast Ultrasound (ABUS) system as an appendage to mammography for breast cancer cases (symptomatic/asymptomatic), in Canada.

Medical Devices Bureau of Health Canada is responsible for evaluating medical device safety, efficacy and quality; somo•v ABUS system has been one, solely approved by the agency.

FDA has even sanctioned the somo•v ABUS system in the US for ancillary diagnostic approach with mammography.

Elated with the approval, Ron Ho (President and CEO, U-Systems) now is up to make the technology available for breast cancer patients, in Canada, for better diagnosis and treatment.

He said, somo•v Automated Breast Ultrasound System has not been devised to substitute mammography, but the combined efforts of ultrasound & mammography will be utilized for enhanced cancer detection, than mammography alone.

The technology is ideally fit for high-volume set-ups; somo•viewer™ (3D workstation) facilitates for swift review and storage of patient exams, to optimize workflow.

U-Systems has even patronized national SOMO•INSIGHT Clinical Study, to assess feasibility of the combination – digital mammography with somo•v Automated Breast Ultrasound System over routine mammogram for breast cancer detection, in women.

More than 15,000 female subjects partook in the clinical study, and it recognized considerable amount of patients that showed negative on mammogram, but recognized well through ABUS system.

BIRADS score can be utilized for mucocele-like lesions related with Atypical Ductal Hyperplasia.

Intermediate concern calcifications of breast malignancy were detected more often in mucocele like breast lesions related with ADH.

 

The medical research study was conducted by Sun Mi Kim, Hak Hee Kim, Doo Kyung Kang, Hee Jung Shin, Nariya Cho, Jeong Mi Park and Joo Hee Cha from Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, South Korea; Department of Radiology, Division of Breast Imaging and Intervention, University of Iowa Hospitals, Iowa City, IA; Department of Radiology, Seoul National University Bundang Hospital, Seongnam-Si, South Korea; Department of Diagnostic Radiology (Ajou University, College of Medicine, Suwon and Department of Diagnostic Radiology, Seoul National University, Seoul, South Korea.)

The study is available in online journal of American Roentgen Ray Society, and the research objective was to assess varied radiological findings of mucocele-like tumors of the breast and tumors related with Atypical Ductal Hyperplasia (ADH) as per Breast Imaging Reporting and Data System (BIRADS) and sonographic cystic mass classification (Note: though the condition is not cancerous, but women with ADH have greater tendency for cancer.)

In a period of ten years, about 68 women with 72 mucocele like breast lesions were evaluated in a microscopic study at three medical institutions.

Through contemplative study – ultrasound and mammographic findings of 72 mucocele like breast lesions were analyzed by, in accordance with BIRADS scale, and radiological study results were associated with pathological results.

Mammography demonstrated 53 breast lesions with calcifications, with and without a mass: 39 were calcifications without a mass. Intermediate concern calcifications of breast malignancy were detected more often in mucocele like breast lesions related with atypical ductal hyperplasia, in comparison to pure mucocele-like tumors. About 69 of mucocele-like tumors showed as cystic lesions on sonography.

Septated/clustered cysts in breast and complex cystic breast masses were often visible in mucocele-like tumors related with atypical ductal hyperplasia. Positive value for breast imaging reporting and data system 4 calcifications was 13.3%, whereas that for BIRAD score of 5 it was 50%, respectively.

Conclusion: Mucocele-like lesions related with atypical ductal hyperplasia (ADH) were often visible as septated/clustered cysts in breast and complex cystic breast masses, associated with intermediate concern calcifications of breast malignancy, and BIRADS score can be utilized for management of mucocele-like tumors.

As per the study put forward at the Cancer Imaging and Radiation Therapy Symposium in Atlanta:

• Annual mammograms furnish similar consequences post breast conserving therapy for cancer patients, at lower health care cost
• Researchers tried to ascertain the clinical relevance and usefulness of follow up mammogram after Breast Conserving Therapy (BCT), when the patient is treated already with treated with a lumpectomy and radiation for stage breast cancer.

The conference was supported by Radiological Society of North America (RSNA) and the American Society for Radiation Oncology (ASTRO).

Annual mammograms are often carried on after BCT. Some of radiologists urge for interval mammogram (follow-up) after 6 months, after primary post-treatment mammogram, which is about 5 months after the culmination of radiotherapy, on the average, to ascertain constancy, to check out for cancer recurrence (Oncology).

For the trial study, about 88 of 467 BCT patients from Abington Memorial Hospital, Abington, PA had an interval mammogram (IM). This contributed to 4 biopsies that did not generate any recurrent or new cancer cases. The patients proceeded further for their annual mammograms after interval mammogram.

Medical researchers ascertained that ruling out IM would bring down higher healthcare costs, with no vital impact on patient outcomes.

Though an IM after BCT is normal, but physicians are required to reconsider their suggestion for an IM, to relieve patients with lower healthcare costs and unneeded biopsies.

Conclusion: Interval Mammograms after Breast Conserving Therapy is not recommended for patients, to save them money and unneeded biopsies.

New U.S. Preventive Services Task Force (USPSTF) cancer screening guidelines potentially bear on endurance in younger patients.

• USPSTF urged against annual mammograms for 40 year old women, if not the patients had genetic disorder, or familiar risk of radiation.
• Full field digital mammography (FFDM) is beneficial over film radiography for younger patients with dense breast mass.

The medical research was conducted by: Paul Dale, M.D., Chief of Surgical Oncology and his colleagues (Nicole Shen, Linda Sue Hammonds, and Dick Madsen) of Ellis Fischel Cancer Center, University of Missouri-School of Medicine, Columbia, MO.

The medical research was put forward at the annual association meeting of American Society of Breast Surgeons.

Mammography for breast cancer proves good to women within the age group of 40-49 years. Leaving out people of this age group from annual mammogram under the reviewed guidelines for mammography – US Preventative Service Task Force (USPSTF), would in harmful way affect endurance.

A 10-year retrospective study carried on at the University of Missouri in Columbia, MO ascertains mammography that discovered out smaller breast tumors with less lymph node metastasis than other recognized through clinical breast screening of women in this age group.

Breast cancer has an improved medical prognosis when cared for prior breast tumors become conspicuous and classifiable through a doctor, or through self breast examination.

The breast cancer research study even ascertained that breast tumors recognized out through mammography in general had ameliorated consequences after discourse than that detected through clinical examinations.

Though the consequences of the medical research were not storming, on grounds of the know-know that Paul Dale has, the confined amount of research analyzing how the new rules of thumb by USPSTF might bear on breast cancer mortality rate was unanticipated.

In spite of substantial protests to new guidelines, few medical researchers have in distinction from others considered at mammography and its long-run affect on cancer (Oncology) outcomes in younger women.

The medical cancer research team of Dr. Dale evaluated data of patients for cancer treatment at tertiary hospital (referral center) in between 1998 and 2008.

About 1581 women were analyzed by – of which 20% were in the age group of 40 and 49, respectively.

Approximately 47% of the patients were analyzed through mammography; 53% were through clinical examinations, and other cancer screening methods.

In case of mammogram, the average size of tumor in the breast was 20 mm in diameter, though in other cancer screening the tumors were 30 mm in diameter.

The research team marks the divergence in tumor size, where the study likewise ascertained that the frequency of lymph node involvement in the clinically distinguished group was all but two times that of patients recognized out through mammogram.

Researchers reckoned the stats of five year disease free survival rate through relative survival methodological analysis, to be 94% for group on mammogram findings, and about 78% for other that did not go through mammogram. The lymph node negativity and tumor size were importantly related to increased survival rates.

The study discovered out that about 20% of women analyzed with breast cancer were under 50 years of age, and all but half of their tumors were identified out through mammography.

Dr. Dale marks that, with respect to latest advancements in directed treatment of early cancer, as per new guidelines – younger cancer patients would miss out chemotherapy, and have vital adverse cancer survival rates, when miss cancer screening, for early detection of tumor.

Conclusion: Mammographic screening in women aged 40-49 discovered out smaller tumors with less lymph node metastasis. Annual mammographic screening is urged for women of 40-49 years for cancer survival rate.

Mayo Clinic and Gamma Medica, Inc. have developed lower dose MBI system – which supports a 4 mCi MBI scan.

• MBI is being conceived to circumvent digital mammography, MRI, ultrasound etc.
• It showed 91% sensitivity (in combination with mammography), and 93% specificity over mammography in 1,000 patients.

In a recent Breast Imaging Meeting by Society of Nuclear Medicine conducted in Bethesda, Maryland from April 21-22, 2011 – Mayo Clinic (Rochester, MN) put forward highly awaited preliminary results of the clinical research studies, of about 2,400 patients on low dose Molecular Breast Imaging (MBI) cancer trial/screening in women with dense breasts.

The cancer clinical trial was funded by Susan G. Komen Foundation.

Women with dense breast that posed for digital mammogram between June 2010 and January 2011 were inscribed for this clinical study.

Research was conducted by Michael O’Connor, PhD – Medical Physicist, Carrie Hruska, PhD – Associate Consultant in Medical Physics, and Deborah J. Rhodes, MD – Lead clinical investigator.

Partakers experienced both molecular breast imaging (MBI) and mammogram. MBI was executed with 296 MBq (8mCi) injection of Tc-99m Sestamibi and dual head czt detectors, and developed in active frame to allow for genesis of 148 MBq (4 mCi) eq images.

MBI’s and mammograms were interpreted separately, where MBI’s were allotted an assessment score of 1-5 over BIRADS (Breast Imaging Reporting and Data System). The assessment scores of 3-5 on molecular breast imaging were conceived positive and contributed to diagnostic work-up.

About 440 women that were examined up to now, 6 patients were determined out with cancers. In line to Mammography – which did not find out any, MBI discovered out cancer in about 5 of 6 patients. The unexpended cancer was noticed on prophylactic mastectomy (7 mm invasive carcinoma).

MBI discovered out 2 cases of DCIS (Ductal Carcinoma In Situ) – 6 and 15 mm, tubular cancer (7mm), and invasive lobular carcinoma (36mm) that were hidden by Mammography.

About 79 women were called back for symptomatic valuation of the conclusion; almost 35 – due to predominant MBI alone; 40 because of incidental mammogram, and 4 due to both the examinations. Around 18 women had passed through diagnostic test/biopsy, where 16 women were cued by MBI, with positive predictive value (PPV) of 25%, while only 2 were being cued by Mammography with PPV of 0%. All the detected cancer cases were even seeable on the 148 MBq (4 mCi) equivalent images.

Though the study is on, but conclusion from this clinical research show out the significance of low-dose MBI, which can be a vital choice to mammography screening in women with dense breast. Medical researchers said, the re-examination after a year for this group, and advance study of incidental screening MBI is required to demonstrate out for sensitivity specificity.

The U.S. Food and Drug Administration have given approval for the for the first three dimensional mammography system.

Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis is expected to increase the accuracy of breast cancer diagnosis.

The Selenia Dimensions System, an upgrade to Hologic’s existing FDA-approved 2-D system, can provide 2-D and 3-D X-ray images of the breasts. The 3-D images may help physicians more accurately detect and diagnose breast cancer.

The Selenia Dimensions System is marketed by Hologic Inc.

See the FDA press release here

Focused breast ultrasound examination (radiology) has proved well in breast biopsy procedures, for breast cancer detection, of women below 40 years of age, affirmed through the study results presented over in the American Journal of Roentgenology.

Breast ultrasound images (utilizing ultrasound equipment/systems) help the physicians identify out breast cancer facts (for recognizing out cyst/tumors in breast), and ultrasound has been urged specifically by medical experts to be considered as primary medical imaging technique for evaluating out breast nodules, painful lumps in breast (oncology), in women below 30 years of age.

For the neophytes, breast ultrasound scan/examination is primarily being used for to diagnose/analyze out breast irregularities (for breast cysts/lumps/tumors), to set apart probable irregularities recognized out on mammography. Medical research scientists affirm that for women below 30 years of age (with focal breast pain/ multifocal breast cancer), focused/concentrated ultrasound scanning is highly preferred than other applicable imaging techniques and modalities, as it has proved by time and testing that ultrasound guided breast biopsy (ultrasonography) is good for primary level image evaluation of the disorder.

But, questions do arise from this and that corner about the effectiveness/preciseness of ultrasound scan (medical imaging equipment), and simultaneous mammography for a mass public.

Medical research scientists took over data from year 2002-2006 on varied patients, identifying and reviewing out ultrasound scan/examinations carried on them, of the patients (women, below 30 years of age) with focal breast pain/multifocal breast cancers (symptoms and other), performed at Seattle Cancer Care Alliance (Seattle, WA). The results were decided on by breast biopsy, ultrasound observation (around 2 months) and by other means!

On the whole, breast malignancy (malignant tumors) recognized out in the research study by the team was around 0.4% (percent), and they affirmed that ultrasound proved very well (100% by all means) in precisely detecting out breast malignant tumors, as because all the tumors were recognized out utilizing the very technique, of ultrasonography. For the same reason (as ultrasound proved well), there was no scope left for mammography to come in picture, and prove anything wrong, or help in more effective diagnosis, as the results (through ultrasound) showed 100% negative predictive value (of the patients who were precisely diagnosed on breast tumors).

On the concluding note, the importance of ultrasound sonography (diagnostic sonography) has definitely been proved by all means to be a good medical imaging technique for primary evaluation of focal breast pain/multifocal breast cancer in young women (below the age of 30 years, and so).

Cross checking through the patient’s total past exposure, and then carefully weighing the risks and benefits of each test and any alternative approaches that can be taken is a good approach to reduce excessive Radiation Risks.

There are two new studies appearing in the Tuesday’s issue of the journal Radiology which suggested more physicians should take this approach. It was also found in a recent study that certain nuclear-based breast imaging exams that involve injecting radioactive material into patients expose women to far higher doses of radiation than regular mammography, increasing their risk of cancer in vulnerable organs beyond the breast, like the kidneys, bladder or ovaries. Over all, the United States population’s annual radiation dose from medical procedures increased sevenfold between 1980 and 2006, a second paper reports.

A latest article published by Roni Caryn Rabin in The New York Times shows how Dr. Deborah Rhodes approaches radiation tests is a remarkable study. Before she orders for a diagnostic test that involves radiation, she consults a chart in her office that lists the amount of radiation exposure from each test. She considers the patient’s total past exposure, and then carefully weighs the risks and benefits of each test and any alternative approaches she can take. “I’m a radiation phobe — I’ll come right out and say this,” said Dr. Rhodes, an internist at the Mayo Clinic who is doing research to develop screening technologies that require less radiation exposure to the patient. “I’m constantly monitoring radiation doses in my patients.”

She also mentioned, “this is something that isn’t well understood, not just by the public — but by physicians who order the tests.” R. Edward Hendrick is a physicist who has studied breast imaging for almost 30 years, said he was motivated to quantify the radiation exposure from nuclear breast imaging technologies in a published paper because of similar concerns.

“I would go to the international breast meeting and the big radiology meetings, and nobody had a clue what the doses and risks were,” Dr. Hendrick said. “They’re treating all the tests as if they have the same radiation dose and risk as mammography, and the truth is they have a much, much higher risk. The point of the paper was to say that not all the breast imaging procedures have comparable risks and doses.”

Dr. Hendrick who is a clinical professor of radiology at the University Colorado-Denver School of Medicine in Aurora, Colo., is also a consultant to G.E. Healthcare regarding digital breast tomosynthesis, another breast imaging technique, and is on the medical advisory boards of Koning and Bracco, which make other imaging technologies. The nuclear technologies breast-specific gamma imaging (B.S.G.I.) and positron emission mammography (P.E.M.) are meant to be used as complements or adjuncts to mammography and ultrasound, once there is concern about a cancerous lesion, and not for routine screening. These technologies are also more useful in women who have very dense breast tissue, when mammography often does not provide clear images.

It is noticed that a single breast-specific gamma imaging or positron emission mammography exam exposes patients to a risk of radiation-induced cancer that is comparable to the risk from an entire lifetime of yearly mammograms starting at 40, according to Dr. Hendrick’s study. While digital mammography has an average lifetime risk of inducing 1.3 fatal breast cancers per 100,000 women aged 40 at exposure, a single B.S.G.I. exam was estimated to involve a lifetime risk 20 to 30 times greater in women aged 40, and the lifetime risk of a single P.E.M. was 23 times greater.

Moreover, mammography only increases a woman’s risk for breast cancer while B.S.G.I. and P.E.M. increase the risk of cancer in other organs, such as the intestines, kidneys, bladder, gallbladder, uterus, ovaries and colon, the recent study declared. There is also a concern that use of the imaging technologies will become more widespread and casual. “B.S.G.I. and P.E.M. are great tools for problem solving, if you have a patient with an abnormal mammogram and you’re not really sure,” said Dr. Rhodes. “The problem is these tests are now being considered and even being used in some cases as screening tests, and this is not appropriate.”

“I’m not saying ‘Don’t do the test,’ I’m just saying ‘Don’t prescribe these tests willy-nilly like you would an ultrasound exam,’ ” Dr. Hendrick said.

A few suggested proposals namely for curbing excessive use of imaging include developing national evidence-based appropriateness criteria for imaging, educating referring physicians and the public, curbing the physician practice of self-referral and finding ways to reduce duplicate exams. William R. Hendee, a distinguished professor of radiology, radiation oncology, biophysics and bioethics at the Medical College of Wisconsin in Milwaukee, called on radiologists to spearhead a campaign to reduce overuse of imaging technologies that expose patients to radiation unnecessarily and drive up health costs in the process

“The comparison to mammography is a bit like comparing apples to oranges,” said Doug Kieper, vice president of science and technology for Dilon Technologies Inc., which developed the B.S.G.I. technology. “This is not being used as a screening procedure for the general asymptomatic population who have no indication of disease.” He added that studies were already under way to see if the same results could be obtained using lower doses of radiation.