| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [surabhi.27789@gmail.com].
- 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.
- 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. |