| CTRI Number |
CTRI/2025/10/095889 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
esting a Real-Time Dye Imaging Technique to Find and Remove Hidden Cancer Spots During Surgery in Women with Advanced Ovarian Cancer |
|
Scientific Title of Study
|
Performance Evaluation of Real-time Fluorescence-guided Resection of Peritoneal Metastases in Ovarian Cancer USing IndoCyanine Green during Interval Cytoreductive Surgery (FOCUS-ICG) |
| Trial Acronym |
FOCUS ICG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sampada Vivek Joshi |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences- Jodhpur |
| Address |
Room no. 509, 5th floor, A block, department of Surgical Oncology, OPD building, AIIMS Jodhpur, Basni(Phase-II) industrial area
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9657541321 |
| Fax |
|
| Email |
drsampadajoshi96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nivedita Sharma |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences- Jodhpur |
| Address |
Room no. 509, 5th floor, A block, department of Surgical Oncology, OPD building, AIIMS Jodhpur, Basni(Phase-II) industrial area
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9657541321 |
| Fax |
|
| Email |
nivsha1985@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sampada Vivek Joshi |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences- Jodhpur |
| Address |
Room no. 509, 5th floor, A block, department of Surgical Oncology, OPD building, AIIMS Jodhpur, Basni(Phase-II) industrial area
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9657541321 |
| Fax |
|
| Email |
drsampadajoshi96@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
OPD 509, block A, OPD building AIIMS Jodhpur |
| Type of Sponsor |
Government 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 |
| Sampada Vivek Joshi |
All India Institute of Medical Sciences, Jodhpur |
Room no. 509, 5th floor, A block, department of Surgical Oncology, OPD building, AIIMS Jodhpur, Basni(Phase-II) industrial area
Jodhpur
RAJASTHAN |
9657541321
drsampadajoshi96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C56||Malignant neoplasm of ovary, (2) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (3) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (4) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraoperative administration of Indocyanine green dye during Interval cytoreduction surgery for ovarian cancer |
Indocyanine green (ICG) ( 25 mg vial) will be reconstituted with 5 mL of sterile water for injection under sterile conditions. A dose of 0.1 mg/kg body weight will be administered via a peripheral intravenous line as a rapid bolus, followed by a 10 mL normal saline flush. A maximum of two boluses per patient will be allowed, based on intraoperative need. All contraindications will be ruled out based on the ICG product insert prior to administration.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1.Female patients aged more than 18 years with histolopathologically confirmed ovarian cancer, FIGO stage III or IV and completed more than or equal to three cycles of platinum-based neoadjuvant chemotherapy and scheduled for an interval cytoreductive surgery
2.ECOG performance status 0 to 2
3.Provided written informed consent
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the detection rate of additional peritoneal nodules with near-infrared fluorescence (NIRF) imaging with indocyanine green (ICG) in identifying occult peritoneal metastases during interval cytoreductive surgery in patients with ovarian cancer. |
Detection rate will be calculated based on intraoperative findings and histopathological reports within first 6 months of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the Identification rate, histopathological positivity rate of ICG fluorescence-guided biopsies during interval cytoreduction & other diagnostic accuracy parameters like positive predictive value & sensitivity.
2.To determine whether fluorescence guidance during interval cytoreduction alters the extent of surgical resection & identify subset of patients in whom it is ideal.
3.To determine technical challenges & develop optimal guidelines for intraoperative utility of the fluorescence imaging
4.To generate preliminary data for future trials assessing long-term oncologic outcomes- peritoneal recurrence, disease free survival (DFS) & overall survival (OS) at 6 months & 1 year & 2 year (beyond thesis period) |
At 6 months & 1 year & 2 year (beyond thesis period) |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
21/10/2025 |
| 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="1"
Months="6"
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 - 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [drsampadajoshi96@gmail.com].
- For how long will this data be available start date provided 07-10-2025 and end date provided 22-11-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study aims to evaluate the performance of ICG-guided near-infrared
fluorescence imaging in enhancing intraoperative detection of occult peritoneal
metastases during interval cytoreduction surgery in ovarian cancer. Primary
objective is to evaluate the detection rate of additional peritoneal nodules
with near-infrared fluorescence imaging with indocyanine green in identifying
occult peritoneal metastases during interval cytoreductive surgery in patients
with ovarian cancer. Female patients aged more than 18
years with histolopathologically confirmed ovarian cancer, FIGO stage III or
IV and completed more than or equal to 3 cycles of platinum-based neoadjuvant
chemotherapy and scheduled for an interval cytoreductive surgery, ECOG performance status 0 to 2 and provided
written informed consent will be included. This study
addresses a critical gap by evaluating the real-time utility of ICG NIRF
imaging in enhancing intraoperative identification of otherwise occult
disease. By focusing on its performance in the post-chemotherapy setting, our
work aims to clarify whether this technology can support more complete
cytoreduction, guide surgical decision making, and ultimately contribute to
improved outcomes for women with advanced ovarian cancer
|