| CTRI Number |
CTRI/2018/05/014188 [Registered on: 29/05/2018] Trial Registered Prospectively |
| Last Modified On: |
30/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Breast Thermography as a tool to assess response to cancer therapy |
|
Scientific Title of Study
|
Clinical validation of the illumina360 system |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBagyam Raghavan |
| Designation |
Senior Radiology consultant |
| Affiliation |
Apollo specialty cancer hospital |
| Address |
New No.6, Old No.24, Cenotaph Road, Teynampet, Chennai.
Chennai
TAMIL NADU
600035
India |
| Phone |
9444028839 |
| Fax |
|
| Email |
drbagyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aarthe Mohan Raja |
| Designation |
Program Manager - ILLUMINA |
| Affiliation |
Cura Healthcare Pvt.Ltd |
| Address |
Plot # 32, Phase-I, Mepz Sez, Tambaram, Kadapperi, Chennai, Tamil Nadu
Kancheepuram
TAMIL NADU
600045
India |
| Phone |
8939921272 |
| Fax |
|
| Email |
aarthee.m@cura.in |
|
Details of Contact Person
Public Query
|
| Name |
DrBagyam Raghavan |
| Designation |
Senior Radiology consultant |
| Affiliation |
Apollo specialty cancer hospital |
| Address |
Radiology department, Consultation room, Apollo Specialty cancer hospital, New No.6, Old No.24, Cenotaph Road, Teynampet, Chennai.
Chennai
TAMIL NADU
600035
India |
| Phone |
9444028839 |
| Fax |
|
| Email |
drbagyam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cura health care Pvt ltd
Plot # 32, Phase-I, Mepz Sez, Tambaram, Kadapperi, Chennai, Tamil Nadu 600045 |
|
|
Primary Sponsor
|
| Name |
Cura health care Pvt ltd |
| Address |
Plot # 32, Phase-I, Mepz Sez, Tambaram, Kadapperi, Chennai, Tamil Nadu 600045 |
| Type of Sponsor |
Other [healthcare industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrBagyam Raghavan |
Apollo Specialty Cancer Hospital |
Radiology department, Consultation room, Apollo Specialty Cancer Hospital, New No.6, Old No.24, Cenotaph Road, Teynampet, Chennai, Tamil Nadu 600035
Chennai
TAMIL NADU |
9444028839
drbagyam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee - clinical studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) Positive biopsy finding in one or both breast.
(2) Age between 18 to 75 years.
(3) Require Neoadjuvant chemotherapy(NACT).
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breast Thermography |
Model:illumina360 Description:Rotational thermography unit for breast screening. This is required to image the breast in 360 degree views without involving any radiation and without touching the breast. |
| Comparator Agent |
Breast Ultrasound |
Manufacturer 1: GE; Model: S8 Manufacturer 2: Philips; Model: IU22
This is required to compare the findings from thermography with the standard examination results from ultrasound. |
| Comparator Agent |
PET CT |
Manufacturer: Philips Model: Gyroscan
This is used as an additional comparator in the study to compare the findings from thermography with PET CT when Ultrasound results are inconclusive. Only in PET CT, the examination involves radiation and intervention for contrast agent. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
(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. |
|
| ExclusionCriteria |
| Details |
(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.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/06/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |