| CTRI Number |
CTRI/2024/09/074039 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Indocyanine green(ICG) dye for axilla treatment in breast cancer patients |
|
Scientific Title of Study
|
Use of Indocyanine green (ICG) dye for Sentinel lymph node biopsy in Breast cancer patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jnaneshwari Jayaram |
| Designation |
Associate Professor, |
| Affiliation |
Father Muller Medical College, |
| Address |
Department of Surgical Oncology, Father Muller Medical College, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
09742954025 |
| Fax |
|
| Email |
jnaneshwari.j@fathermuller.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jnaneshwari Jayaram |
| Designation |
Associate Professor, |
| Affiliation |
Father Muller Medical College, |
| Address |
Department of Surgical Oncology, Father Muller Medical College, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
09742954025 |
| Fax |
|
| Email |
jnaneshwari.j@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Jnaneshwari Jayaram |
| Designation |
Associate Professor, |
| Affiliation |
Father Muller Medical College, |
| Address |
Department of Surgical Oncology, Father Muller Medical College, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
09742954025 |
| Fax |
|
| Email |
jnaneshwari.j@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Research Centre
Father Muller Medical College, Kankanady
Mangalore
Karnataka
India- 575002 |
|
|
Primary Sponsor
|
| Name |
Father Muller Research Centre |
| Address |
Father Muller Research Centre
Father Muller Medical College,
Kankanady
Mangalore
Karnataka
India- 575002 |
| 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 |
| DrJnaneshwari Jayaram |
Father Muller Medical College |
Department of Surgical Oncology,
Dakshina Kannada
KARNATAKA |
09742954025
jnaneshwari.j@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTE |
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 |
INDOCYANINE GREEN DYE |
USING INDOCYANINE GREEN DYE FOR FOR SENTINEL LYMPHN NODE BIOPSY for 1 year |
| Comparator Agent |
nill |
nill |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
upfront operable breast cancer patients |
|
| ExclusionCriteria |
| Details |
1. Known allergy to iodine/ ICG
2. Post neo-adjuvant chemotherapy patients
3. Patients refusing for the study
4. Pregnancy associated breast cancer
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of sentinel nodes( identification rate) and their pathological assessment ( positive rate) by frozen section. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
safety
feasibility |
1 year |
|
|
Target Sample Size
|
Total Sample Size="59"
Sample Size from India="59"
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 3 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Breast cancer is on the rise in India and there is a dearth of awareness of the problem and its consequences in our society. Axillary lymph node status provides important prognostic information in invasive breast cancer. Management of involved axilla has evolved over time. Fisher et al were the first to support the hypothesis that axillary dissection has prognostic significance. This led to the use of various options in the management of axilla including axillary lymph node dissection (ALND), axillary clearance, axillary dissection with regional lymph node radiation, regional radiation alone, axillary sampling, sentinel lymph node biopsy (SLNB) and observation only.SLNB can be done using various dyes such as methyelene blue, fluroscein, radiocolloid, indocyanine green(ICG). Using ICG dye, the sentinel node can be visualised using infrared light. With the intention of making SLNB as a standard procedure of choice we want to conduct a validation study using ICG for identification of sentinel node and by frozen section method followed by Axillary lymph node dissection in all patients there by assessing the accuracy, safety, and feasibility of SLNB in breast cancer patients at our institution. |