| CTRI Number |
CTRI/2024/09/073173 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Diagnostic Accuracy of Indocyaninegreen guided SLNB after Neoadjuvant treatment in Breast Cancer |
|
Scientific Title of Study
|
Diagnostic Accuracy of Indo Cyanine Green guided Sentinel
lymph node biopsy after Neoadjuvant treatment in Breast
Cancer |
| 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.Sharmila beevi.J |
| Designation |
Senior Resident, Department of Surgical Oncology,JIPMER |
| Affiliation |
JIPMER |
| Address |
Department of Surgical Oncology JIPMER Campus Road JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8122492582 |
| Fax |
|
| Email |
sharmi440@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Pradeep Subramani |
| Designation |
Assistant Professor , Department of Surgical Oncology,JIPMER |
| Affiliation |
JIPMER |
| Address |
Department of Surgical Oncology JIPMER Campus Road JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9842626315 |
| Fax |
|
| Email |
drspradeep86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Sharmila beevi.J |
| Designation |
Senior Resident, Department of Surgical Oncology,JIPMER |
| Affiliation |
JIPMER |
| Address |
Department of Surgical Oncology JIPMER Campus Road JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8122492582 |
| Fax |
|
| Email |
sharmi440@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Dhanvantri nagar , Jipmer campus road,JIPMER-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSHARMILA BEEVIJ |
JIPMER |
Room no 5322,3rd Floor, SSB block,Dhanvantri nagar, JIPMER campus road,JIPMER-605006
Pondicherry
PONDICHERRY |
8122492582
sharmi440@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER,INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES CDSCO Reg. No. ECR/342/Inst/PY/2013/RR-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N648||Other specified disorders of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indocyanine green dye |
In the operating room, after induction of anesthesia and after the
preparation of the surgical field, surgeon will prepare ICG (Aurogreen, 25
mg reconstituted with 10 mL of distilled water) and 3 ml(7.5mg) is
withdrawn and 1 ml is injected in each periareolar site, at 6, 9, 12 o’clock
for Right breast and 3,6,12 o’clock for left breast.
â— After the injection, the breast will be gently massaged for 5-10 minutes.
â— Then the lymphatic pathway will be traced with the use of the fluorescence |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age 18 years or older
2. ECOG Performance Status of 0 to 2
3. Breast cancer with clinically node negative after
neoadjuvant treatment. |
|
| ExclusionCriteria |
| Details |
1. Previous Surgery/Radiotherapy to breast or
axilla.
2. Pregnant or nursing mothers.
3. Patients with ICG allergy
4. T4 and N3 disease before Neoadjuvant
treatment
5. Patients with Extra axillary lymph nodes
6.Patients with distant metastasis
7. Patients not giving consent for SLNB
8. Progressive disease after Neoadjuvant treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the Sensitivity and specificity of Indo Cyanine
Green (ICG) for detecting sentinel lymph nodes after
neoadjuvant treatment among breast cancer patients
undergoing surgery. |
At baseline and at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sentinel node Identification rate, False negativity rate |
at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/09/2024 |
| 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="2"
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
|
Background: In breast cancer Axillary lymph node status is one of the most important prognostic factors in patients with breast cancer. Axillary lymph node dissection is an integral part of surgical management. However, it may lead to increased morbidity such as impaired sensation (56%), Chronic pain (37%) and also debilitating lymphedema (21.4%) in some patients which is irreversible leading to poor functional outcome Rationale : ICG is a tricarbocyanine dye which fluoresces, i.e. emits light, after excitation under near- infrared light at 806)nm light. ICG is highly soluble in water and binds to β-lipoproteins, particularly to albumin. Because of the high protein content of lymph, ICG accumulates in the lymphatic pathways and lymph nodes. ICG- dyed lymph nodes become visible 5 minutes after light excitation and remain visible for around 60 minutes Optical imaging using the near-infrared (NIR) üuorescence lymphatic tracer using indocyanine green (ICG) has shown promising results as an alternative for, or an addition to, conventional SLN mapping. The role of ICG fluorescence alone in detecting SLNin the post neoadjuvant treatment setting has been reported in a few studies. Expected outcome:The expected outcome of the study is to know the accuracy of ICG in the identification of sentinel lymph nodes after neoadjuvant treatment in carcinoma breast patients undergoing surgery. If found to be accurate, this study could contribute to de-escalating the axillary management among breast cancer patients in the post neoadjuvant treatment setting. |