Thermography for Radiation Dermatitis

Overseen By William T Tran, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Dermatologic abnormalities, Connective tissue disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether thermal imaging (a type of heat-sensitive photography) can measure skin problems caused by radiotherapy. Patients with breast or head and neck cancer often experience skin issues such as redness and peeling from this treatment. The study uses non-invasive thermal imaging to monitor these effects. Ideal candidates for this trial are those currently receiving radiotherapy for breast or head and neck cancer and do not have other skin conditions like open sores or psoriasis. As an unphased trial, participants can contribute to innovative research that may enhance the monitoring of radiotherapy side effects.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that thermography is safe for measuring radiation-induced skin toxicity?

Research has shown that thermography, which uses heat-sensing cameras, is generally safe. It is non-invasive, meaning it doesn't involve entering the body or surgery, making it comfortable for most people. The FDA has approved thermography for use alongside other screening tests, but not as a replacement. While thermography is safe, it isn't fully trusted to diagnose diseases on its own. No known harmful side effects exist from using thermography, reassuring those considering it as part of their treatment plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for skin toxicity from radiotherapy rely on topical creams and medications to manage symptoms after they appear. However, thermal imaging is unique because it offers a non-invasive way to monitor changes in the skin's temperature, potentially identifying problems before they become severe. Researchers are excited because this method could allow for earlier intervention and personalized adjustments to treatment, possibly reducing discomfort and improving outcomes for patients undergoing radiotherapy.

What evidence suggests that thermal imaging is effective for measuring radiation-induced skin toxicity?

Research has shown that thermography, a type of heat imaging, can detect changes in skin temperature that might indicate skin problems. In this trial, participants will undergo thermal imaging of their whole breast or head and neck cancer site during radiotherapy treatment. Studies have found that these heat images can predict skin issues like redness and peeling in patients undergoing radiotherapy, particularly for head and neck cancer. This technology has also detected breast cancer, showing results that closely match traditional ultrasound methods. Overall, thermography is non-invasive and can identify potential skin problems early, making it a promising tool for monitoring skin during cancer treatments. ^{1 6 7 8 9}

Who Is on the Research Team?

William T Tran, PhD

Principal Investigator

Clinician Scientist

Are You a Good Fit for This Trial?

Inclusion Criteria

Biopsy-confirmed diagnosis of breast cancer (Stage 0-III) or head and neck cancer (all subtypes; stage I - IV) according to American Joint Committee on Cancer staging criteria.

Subjects must give appropriate written informed consent prior to participation in the study

Subjects must be able and willing to comply and understand the instructions associated with the imaging procedure.

Exclusion Criteria

Subjects with any pre-existing dermatologic abnormalities (open sores, keloids, psoriasis) involving the treated breast or head and neck.

Subjects who are pregnant or lactating (which usually preclude them from radiotherapy)

You have very hairy skin that prevents accurate measurement of heat output.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy Treatment

Participants undergo radiotherapy treatment with weekly thermal imaging to evaluate skin toxicity

1 year

Weekly visits for thermal imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Thermography

How Is the Trial Designed?

Group I: Thermal Imaging Experimental Treatment 1 Intervention

Patients will undergo non-invasive, thermal imaging of their whole breast or head and neck cancer site, during the course of the radiotherapy treatment, at weekly time intervals.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9731505/

Thermography as a Breast Cancer Screening Technique This review discusses the benefits of thermography showing that it can be a significant modality for breast cancer screening.

2. nature.com nature.com/articles/s41598-025-09330-2

Harnessing infrared thermography and multi-convolutional ... Several studies have shown that thermal infrared imaging, also known as thermography, can yield substantial early screening outcomes regarding ...

3. mdpi.com mdpi.com/2306-5354/12/6/639

Breast Cancer Detection Using Infrared Thermography This survey uniquely focuses on integrating texture analysis and machine learning within infrared thermography for breast cancer detection.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11844184/

The potential of thermal imaging as an early predictive ... Thermal images acquired from patients undergoing radiotherapy for head and neck cancer can be used as an early predictor of grade ≥ 2 RD and may ...

5. archbreastcancer.com archbreastcancer.com/index.php/abc/article/download/1048/1059/12765

Evaluation of Breast Thermography Images According to ... Breast thermography showed an 86.72% diagnostic agreement with ultrasound, highlighting its potential as a complementary, non-invasive, and cost ...

6. iowaradiology.com iowaradiology.com/fda-warns-against-using-thermography-in-place-of-mammography/

FDA Warns Against Using Thermography in Place of ... The FDA has cleared the marketing of thermography for use with additional screening or diagnostic tests like mammography, it has not approved the technology.

7. hpo-docs.jh.edu hpo-docs.jh.edu/5fLfPUsG

Johns Hopkins Health Plans Medical Policy Manual Medical ... The FDA reported there is no valid scientific data to demonstrate that thermography devices, when used on their own or with another diagnostic ...

8. fda.gov fda.gov/news-events/press-announcements/fda-issues-warning-letter-clinic-illegally-marketing-unapproved-thermography-device-warns-consumers

FDA issues warning letter to clinic illegally marketing ... The FDA also issued a safety communication to warn patients that thermography is not cleared by the FDA as an alternative to mammography and ...

9. oncnursingnews.com oncnursingnews.com/view/fda-warns-patients-providers-about-thermography-imaging-to-diagnose-cancer

FDA Warns Patients, Providers About Thermography ... The FDA is warning patients and providers not to use thermography in place of mammography to detect, diagnose, or screen for breast cancer.