Where is Computerized Thermal Imaging Being Evaluated?

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Thermography / Computerized Thermal Imaging

Where is Computerized Thermal Imaging Being Evaluated?

The computerized thermal imaging (CTI) technology is currently being tested in clinical trials to determine its effectiveness. The manufacturer of CTI technology recently received acceptance from the FDA for module three of its premarket approval application (PMA). This is the third of five modules to be submitted. Each of the five modules contains a portion of the data needed for FDA review. Currently, CTI technology is being evaluated in clinical trials at five U.S. medical facilities:

  • USC/Norris Comprehensive Cancer Center, Los Angeles, California
  • Providence Hospital, Washington, DC
  • Mt. Sinai Medical Center, Miami Beach, Florida
  • St. Agnes Hospital, Baltimore, Maryland
  • Lahey Center, Boston, Massachusetts

The clinical trials will determine whether the addition of the CTI technology to mammography and clinical breast exams helps differentiate between normal and malignant (cancerous) breast tissue.

What are the Limitations to Computerized Thermal Imaging?

Though computerized thermal imaging (CTI) may provide a pain-free breast imaging exam and has the potential to detect cancer by identifying abnormal heat patterns in breast tissue, there are some limitations to the technology. Since CTI is based on the principles of thermography, it may give false-positive results as thermography often does. A false positive result indicates cancer when no cancer is present. Thermography has a false positive rate of approximately 25%. However, CTI uses more advanced technology and a different exam process than thermal imaging. Thus, clinical trials may find that false positive results are less likely with CTI.

In addition, CTI cannot detect microcalcifications (tiny calcium deposits that may indicate the presence of cancer). Tumors that contain calcifications may be more difficult to remove completely. Microcalcifications can only be seen reliably with mammography. Approximately 50% of the breast cancers detected by mammography appear as a cluster of microcalcifications. Other imaging exams, including thermography, do not provide the fine detail (spatial resolution) that is available with conventional x-ray mammography. However, adjunct exams (such as ultrasound,   MRI, etc.,) may be beneficial in some cases because they provide excellent contrast resolution, which may make some abnormalities such as cysts easier to see since these areas "stand out" more from surrounding tissue.

Cost is another limitation of the CTI technology. The manufacturer of CTI technology is only seeking FDA approval for the exam to be used in addition to mammography to help screen for breast cancer. Because mammography will have to be performed regardless of whether or not thermal imaging is done, many physicians question whether CTI technology will drastically change how breast cancer is detected. Many facilities that perform breast imaging tests to screen for breast cancer may be unable or unwilling to acquire additional costly imaging technology if they do not see a significant benefit to the patient.

What Imaging Exams are Currently FDA Approved to Help Detect Breast Cancer?

Mammography is currently the only FDA approved exam to help screen for breast cancer in women who show no signs or symptoms of the disease. Screening mammography is recommended on an annual basis for all women once they reach 40 years of age. If a suspicious region is detected with screening mammography or by physical exam, the physician may order diagnostic mammography (involves more views than screening mammography) and/or other breast imaging exams.

Other imaging exams FDA approved as supplements to mammography for diagnosis include:

To help detect breast cancer at an early stage when the chances for successful treatment are the greatest, women should follow the guidelines set by the American Cancer Society:

  • All women between 20 and 39 years of age should practice monthly breast self-exams and have a physician performed clinical breast exam at least every three years.
  • All women 40 years of age and older should have annual screening mammograms, practice monthly breast self-exams, and have yearly clinical breast exams. The clinical breast exam should be conducted close to and preferably before the scheduled mammogram.
  • Women with a family history of breast cancer or those who test positive for the BRCA1 (breast cancer gene 1) or BRCA2 (breast cancer gene 2) mutations may want to talk to their physicians about beginning annual screening mammograms earlier than age 40, as early as age 25 in some cases.

Additional Resources and References

Updated: May 4, 2008