| CTRI Number |
CTRI/2026/03/106794 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using Indocyanine Green Dye to identify the first lymph nodes affected in women with Early-stage Ovarian Cancer |
|
Scientific Title of Study
|
Feasibility of Sentinel Node Mapping Using Indocyanine green (ICG)-in Early Epithelial Ovarian Cancer: A Pilot 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 |
Shagun Kapoor |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Gynae office, 7th floor, MCH Block, Department of Obstetrics and Gynecology, AIIMS, New Delhi
South West
DELHI
110023
India |
| Phone |
07838285979 |
| Fax |
|
| Email |
kapoor.shagun10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoti Meena |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Gynae office, 7th floor, MCH Block, Department of Obstetrics and Gynaecology, AIIMS, New Delhi
South West
DELHI
110023
India |
| Phone |
9953937130 |
| Fax |
|
| Email |
drjyotirajesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shagun Kapoor |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Gynae office, 7th floor, MCH Block, Department of Obstetrics and Gynaecology, AIIMS, New Delhi
South West
DELHI
110023
India |
| Phone |
07838285979 |
| Fax |
|
| Email |
kapoor.shagun10@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi |
| 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 |
| Shagun Kapoor |
AIIMS, New Delhi |
Gynae office, 7th floor, MCH Block, Department of Obstetrics and Gynaecology, AIIMS, New Delhi
South West
DELHI |
07838285979
kapoor.shagun10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee for postgraduate research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indocyanine green dye based sentinel node mapping |
• In the cases with suspected epithelial ovarian cancer, sentinel lymph node (SLN) mapping will be performed using indocyanine green (ICG). ICG will be injected into the perivascular connective tissue of the ovarian ligament to assess pelvic lymph nodes and into the infundibulopelvic ligament to assess paraaortic lymph nodes of the affected ovary/ovaries. Sentinel lymph node mapping will commence at the pelvic level, encompassing the external iliac, obturator, and internal iliac regions, followed by evaluation of the para-aortic regions. Visualization will be performed 15–20 minutes after dye injection using a near-infrared fluorescence imaging system [IMAGE1 S™ Rubina® platform (Karl Storz)] to delineate lymphatic drainage pathways and identify sentinel lymph nodes. In cases of failed mapping, site-specific lymphadenectomy will be performed, and any enlarged lymph nodes will be excised.
• All identified sentinel lymph nodes of histologically proven epithelial ovarian cancer (by intra-operative frozen section) will be submitted for histopathological examination, including ultrastaging. Nodes will be sectioned at 2-mm intervals using step-sectioning to identify metastases.
• Following SLN mapping, systematic pelvic and retroperitoneal lymphadenectomy up to the renal vein, together with comprehensive surgical staging procedures (hysterectomy, bilateral oophorectomy and salpingectomy (BOS), infracolic omentectomy (ICO), peritoneal wash cytology (PWC), and metastatectomy) will be performed.
|
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
• Women aged more than eighteen years
• Women with suspected/Histologically confirmed (frozen section acceptable) stage I-II epithelial ovarian/tubal/peritoneal carcinoma undergoing primary staging
• No radiologically suspicious nodes (short-axis less than ten mm and no malignant morphology).
• Able to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
• Intra-operative finding of carcinomatosis/extra-ovarian disease before SLN injection (Stage IIIC /IV disease)
• Previous surgery on one or both ovaries
• Prior h/o cytoreductive surgery or neoadjuvant chemotherapy or recurrent disease
• Presence of bulky nodes (more than two cm)
• Non-epithelial histologies
• Known allergy to ICG/iodine or prior anaphylaxis to contrast dyes.
• Previous history of RT for any malignancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Detection rate parameters:
• Number of patients in whom at least one sentinel lymph node (SLN) is detected (per-patient detection rate)
• Number of nodal fields in which sentinel lymph nodes are detected (per-nodal field detection rate)
• Number of cases with mapping failure (no SLN detected)
|
Assessed intraoperatively at the time of sentinel lymph node mapping during primary surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Assessment of laterality & anatomical distribution of SLNs
3. Time from ICG injection to SLN identification.
4. Proportion of SLNs with isolated tumor cells, micrometastases, or macrometastases on ultrastaging
5. Diagnostic accuracy parameters:
•Number of nodes identified with tumor deposits in both sentinel lymph nodes (SLNs) & lymphadenectomy specimens (True Positive).
•Number of nodes identified without tumor deposits in both SLNs & lymphadenectomy specimens (True Negative).
•Number of nodes identified without tumor deposits in SLNs but with tumor deposits in lymphadenectomy specimens (False Negative).
6. Concordance between fluorescence signal detected LN & histopathology assessment
7. Number of patients developing procedure-related adverse events (graded by CTCAE v6.0)
8. Rate of empty packets
|
Assessment of laterality & anatomical distribution of SLNs – Intraoperative; Time from ICG injection to SLN identification – Intraoperative; Proportion of SLNs with isolated tumor cells/micro- or macrometastases on ultrastaging – within 2 weeks; Diagnostic accuracy parameters – within 2 weeks; Concordance between fluorescence-detected LN & histopathology – within 2 weeks; Procedure-related adverse events – up to 30 days; Rate of empty packets – within 2 weeks. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
23/03/2026 |
| 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 - NO
|
|
Brief Summary
|
Conducting this study is essential to determine whether sentinel lymph node (SLN) mapping using indocyanine green (ICG) alone can serve as a safe, feasible, and cost-effective alternative to systematic lymphadenectomy in early-stage epithelial ovarian cancer. Establishing its diagnostic performance and reproducibility is the critical first step toward minimizing surgical morbidity while preserving oncologic accuracy. In the Indian context, where most patients belong to lower socioeconomic strata and extensive surgery increases both cost and postoperative complications, ICG-based SLN mapping offers a low-resource, minimally invasive approach that could deliver comparable staging accuracy with reduced morbidity and faster recovery, making this investigation timely and clinically relevant. |