| CTRI Number |
CTRI/2019/04/018586 [Registered on: 12/04/2019] Trial Registered Prospectively |
| Last Modified On: |
10/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Medical device |
| Study Design |
Other |
|
Public Title of Study
|
A study to establish the role of Thermography in detection and characterisation of suspicious breast lesions. |
|
Scientific Title of Study
|
Descriptive study of thermographic images and correlation with routine conventional imaging (Mammography and supplementary Ultrasonography) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenakshi Thakur |
| Designation |
Professor, Dept. of Radiodiagnosis |
| Affiliation |
Tata memorial hospital |
| Address |
Dept. of Radiodiagnosis,
Main building,
Room No - 124,
Dr E Borges Marg,
Parel
Mumbai MAHARASHTRA 400012 India |
| Phone |
02224177000 |
| Fax |
|
| Email |
thakurmh@tmc.gov.in |
|
Details of Contact Person Scientific Query
|
| Name |
Aarthee Mohan Raja |
| Designation |
Program Manager - ILLUMINA |
| Affiliation |
Cura Healthcare Pvt.Ltd |
| Address |
DP 56, 3rd main Road, Sidco Industrial Estate, Thirumudivakkam, Chennai, Tamil Nadu 600044
Chennai TAMIL NADU 600045 India |
| Phone |
8939921272 |
| Fax |
|
| Email |
aarthee.m@cura.in |
|
Details of Contact Person Public Query
|
| Name |
Aarthee Mohan Raja |
| Designation |
Program Manager - ILLUMINA |
| Affiliation |
Cura Healthcare Pvt.Ltd |
| Address |
DP 56, 3rd main Road, Sidco Industrial Estate, Thirumudivakkam, Chennai, Tamil Nadu 600044
Chennai TAMIL NADU 600045 India |
| Phone |
8939921272 |
| Fax |
|
| Email |
aarthee.m@cura.in |
|
|
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 |
DP 56, 3rd main Road, Sidco Industrial Estate, Thirumudivakkam, Chennai, Tamil Nadu 600044
|
| 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 |
| Dr Meenakshi Thakur |
Tata Memorial hospital |
Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012 Mumbai MAHARASHTRA |
02224177000
thakurmh@tmc.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
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 |
Mammogram |
Model: Senographe DS,
Company:GE |
| Comparator Agent |
Mammogram |
Model:Selenia dimensions (tomosynthesis),
Company - Hologic |
| Comparator Agent |
Ultrasonogram |
Model: Voluson 730 pro BT05 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1.Positive finding on MMG.
2.Age between 18 to 75 years.
3.Willingness to participate in the study - YES
|
|
| ExclusionCriteria |
| Details |
1. Patients who cannot lie down in prone position.
2. Febrile patients.
3. Pregnant and lactating women.
4. Patients who cannot follow the instructions during the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Descriptive study of thermographic images and correlation with routine conventional imaging (Mammography and supplementary Ultrasonography) |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the diagnostic accuracy of thermography with conventional work up as gold standard. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
08/05/2019 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
R Rotational breast thermography Rotational thermography is a novel technique, developed upon conventional thermography, in order to over1come these limitations. Illumina360° (a system for rotational breast thermography) images 360° views of one breast at a time in two different controlled temperatures when is in a freely suspended state. Since the breast is positioned freely into the controlled environment maintained in the device and as the imaging is done using IR camera which is always at a distance from the breast that is being imaged, it is non-invasive, without any radiation and breast compression, without any contact of the camera onto the breast, thus being highly safe and accurate for surface temperature measurements. Primary objective Descriptive study of thermographic images and correlation with routine conventional imaging (Mammography and supplementary Ultrasonography) Secondary objective To assess the diagnostic accuracy of thermography with conventional work up as gold standard. Inclusion Criteria 1.Positive finding on MMG. 2.Age between 18 to 75 years. 3.Willingness to participate in the study - YES Exclusion criteria . 1. Patients who cannot lie down in prone position. 2. Febrile patients.
3. Pregnant and lactating women.
4. Patients who cannot follow the instructions during the study. . Implications The study will help to evaluate the significance of the new thermal imaging device, ILLUMINA360° for use in breast cancer screening by comparing with the recommended gold standard imaging practice.
|