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Breast Thermography as a tool to assess response to cancer therapy

Clinical validation of the illumina360 system

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/014188
Enrollment
60
Registered
2018-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- (1) Positive biopsy finding in one or both breast. (2) Age between 18 to 75 years. (3) Require Neoadjuvant chemotherapy(NACT).

Interventions

Intervention1: PET CT: Manufacturer: Philips Model: Gyroscan Intervention2: Breast Ultrasound: Manufacturer 1: GE
Model: S8 Manufacturer 2: Philips
Model: IU22 Intervention3: Breast Thermography: Model:illumina360 Description:Rotational thermography unit for breast screening. This is required to image the breast in 360 degree views without involv
Model: S8 Manufacturer 2: Philips
Model: IU22 This is required to compare the findings from thermography with the standard examination results from ultrasound. Control Intervention2: PET CT: Manufacturer: Philips Model: Gyroscan This

Sponsors

Cura health care Pvt ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (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 â?? 18 years to 75 years (5)Sex - Female (6)Willingness to participate in the study. (7)Patients who can understand the procedure.

Exclusion criteria

Exclusion criteria: (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. (7) Work out/ exercise in last 4 hours before 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.

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to establish non-invasive method of treatment assessment using rotational thermography device, illumina360 and correlating the findings from thermographic breast images with standard imaging modalities such as USG (ultrasonography) and/or CT/ PET CT.Timepoint: 6 months

Secondary

MeasureTime frame
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/ CT/PETCT)as applicable.Timepoint: 6 months

Countries

India

Contacts

Public ContactDrBagyam Raghavan

Cura Healthcare Pvt.Ltd

aarthee.m@cura.in8939921272

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026