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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.



 
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