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CTRI Number  CTRI/2025/11/097651 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 18/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Screening 
Study Design  Other 
Public Title of Study   Use of green dye to early identify lymphedema in post-surgery breast cancer patients 
Scientific Title of Study   Use of Indocyanine green (ICG) lymphography in early detection of lymphedema and response assessment of compression therapy following axillary dissection in breast cancer patients, a prospective interventional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SURABHI SINGH 
Designation  MCH RESIDENT 
Affiliation  CHRISTIAN MEDICAL COLLEGE 
Address  Endocrine Surgery Office, 2nd Floor, Paul Brand Building, Christian Medical College, Ida Scudder Road, Vellore
Christian Medical College, Ida Scudder Road, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  9503290310  
Fax    
Email  surabhi.27789@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SUPRIYA SEN 
Designation  ASSOCIATE PROFESSOR 
Affiliation  CHRISTIAN MEDICAL COLLEGE 
Address  Endocrine Surgery Office, 2nd Floor, Paul Brand Building, Christian Medical College, Ida Scudder Road, Vellore
Christian Medical College, Ida Scudder Road, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  8220148155  
Fax    
Email  supriyaspeedie@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SURABHI SINGH 
Designation  MCH RESIDENT 
Affiliation  CHRISTIAN MEDICAL COLLEGE 
Address  Endocrine Surgery Office, 2nd Floor, Paul Brand Building, Christian Medical College, Ida Scudder Road, Vellore
Christian Medical College, Ida Scudder Road, Vellore
Vellore
TAMIL NADU
632004
India 
Phone  9503290310  
Fax    
Email  surabhi.27789@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College, Ida Scudder Road, Vellore 632004, Tamil Nadu, India 
 
Primary Sponsor  
Name  Christian Medical College 
Address  Ida Scudder Road, Vellore 632004, Tamil Nadu, India 
Type of Sponsor  Private medical college 
 
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 SURABHI SINGH  Christian Medical College  Endocrine Surgery Office, 2nd Floor, Paul Brand Building, Christian Medical College, Ida Scudder Road, Vellore
Vellore
TAMIL NADU 
9503290310

surabhi.27789@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD (IRB)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Indocyanine green dye (ICG)  Use of Indocyanine green (ICG) dye to detect early lymphedema using lymphography Dose will be 0.3 ml of ICG solution (25mg mixed with 5ml of saline) Route of administration will be intradermal injection (at two sites, 1st and 4th web space of hand) Frequency , procedure will be done twice on follow up (1st at 3 to 6 month and 2nd at 7 to 12 month of surgery) Total duration of intervention will be 15min that is 15 minutes after injection, circumferential fluorescent images of lymphatic drainage channels will be obtained using Infrared camera system. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  All patients undergoing surgery for carcinoma breast including axillary dissection or level one sampling or dissection
 
 
ExclusionCriteria 
Details  Age less than 18 years, having secondary edema due to another cause (not breast cancer related), iodine allergy, patient undergoing SLNB or recurrence following previous breast cancer surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Early detection of early(subclinical) lymphedema after breast cancer surgery using ICG lymphography  3 to 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Identify patients having high risk of developing Lymphedema by the use of ICG lymphography pattern following breast cancer surgery.
Institute early compression physiotherapy or intervention by lymphovenous anastomosis for treatment of lymphedema
Assess the response to treatment using ICG lymphography 
6 to 12 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)   01/12/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [surabhi.27789@gmail.com].

  6. For how long will this data be available start date provided 12-03-2027 and end date provided 01-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Upper limb lymphedema is a common complication following breast cancer treatment.  Patient’s quality of life is severely affected. Subclinical lymphedema identification is great help for early treatment and may decrease the chance that the disease will progress to a chronic late stage. Lymphedema can be effectively treated with early identification, resulting in higher success rates and potential cost savings. Incidence of lymphedema varies from 5.6% to 63.4%.

 

The symptoms of early lymphedema may indicate a sub-clinical lymphatic system disorder without a significant increase in arm circumference. This initial dysfunction can be detected through complementary tests such as indirect lymphography or indocyanine green (ICG) lymphography.

 

Indocyanine Green (ICG) lymphography is now commonly used to visualize the lymphatic system. Initially, it was used for breast sentinel node biopsy. Its application extends to lymphoedema diagnosis and mapping lymphatic vessels prior to lymphovenous anastomosis (LVA) surgery. ICG lymphography is a newer technique , has higher specificity and sensitivity than lymphoscintigraphy. It has the advantage of having quick pathological visualization of superficial lymph flow in real time, without any radiation exposure.  It can reliably and accurately diagnose, track, and stage the severity of lymphedema, ranging from sub clinical or early lymphedema to more advanced cases.

 
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