Breast Thermography as a tool to assess response to cancer therapy
- Conditions
- Positive biopsy finding in one or both breast.Age between 18 to 75 years.Require Neoadjuvant chemotherapy(NACT).
- Registration Number
- CTRI/2018/05/014188
- Lead Sponsor
- Cura health care Pvt ltd
- Brief Summary
Breast Cancer is a leading cause of death in women globally. Monitoring response to treatment is a key element in the management of breast cancer that involves several different viewpoints from surgery, radiology and medical oncology. In the neoadjuvant setting, assessing response to chemotherapy prior to surgery to include evaluation for pathologic response can provide prognostic information to help guide follow up care. Current imaging methods such as Ultrasound, X ray mammography and conventional computed tomography imaging can be used to study anatomical characteristics, but may be limited in showing functional and biological changes which start to occur early after treatment initiation.
The primary challenges in the neoadjuvant setting include the accurate assessment of early response to therapy and discovering a non- invasive means of accurately predicting pathologic complete response to therapy.
Illumina360 for breast imaging is a non-invasive, image acquisition and processing system for monitoring the breast tissue changes based on their physiology without any radiation. It comprises a high-resolution IR camera, integrated with the inbuilt temperature control and monitoring system, a multi axial rotating arm and positioning set up that are enclosed within a closed chamber and the special design on its top as the patient couch used for patient positioning. The configuration of the device enables capturing images all through 360 degrees of each breast at two different temperature conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 60
- (1)Positive biopsy finding in one or both the breasts. (2) Age between 18 to 75 years. (3) Patients who can follow the instructions. (4)Age group – 18 years to 75 years (5)Sex.
- Female (6)Willingness to participate in the study. (7)Patients who can understand the procedure.
- (1) Whose clinical condition does not support them lying prone during examination.
- (2) Any infection in the breast that can spread by air or by contact with the patient table.
- (3) Who have body fluid discharge in breast.
- (4) Patients in a medical state who cannot follow explanations given by the clinician to participate in the study.
- (5) Undergone procedure such as EMG, TENS, physical therapy, chiropractic, and any deep heat treatments 24 hours before the exam.
- (6) Consumption of alcohol 12 hours prior to the exam.
- (8) Bathing in last 1 hour from the exam.
- (9) Usage of heat or cold packs on the day of the exam.
- (10) Use of skin creams, perfume, powders or deodorants on the day of the exam.
- (11) Smoking in last 4 hours from the exam.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to establish non-invasive method of treatment 6 months assessment using rotational thermography device, illumina360 and correlating the findings 6 months from thermographic breast images with standard imaging modalities such as USG 6 months (ultrasonography) and/or CT/ PET CT. 6 months
- Secondary Outcome Measures
Name Time Method To characterize the breast tissue changes based on the difference in temperature pattern derived from thermographic breast images against the clinical and imaging findings ( USG/
Trial Locations
- Locations (1)
Apollo Specialty Cancer Hospital
🇮🇳Chennai, TAMIL NADU, India
Apollo Specialty Cancer Hospital🇮🇳Chennai, TAMIL NADU, IndiaDrBagyam RaghavanPrincipal investigator9444028839drbagyam@gmail.com