| CTRI Number |
CTRI/2024/08/073145 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of fluorescence guided surgery for detection of peritoneal metastases in epithelial ovarian cancer patients |
|
Scientific Title of Study
|
Fluorescence guided surgery using Near-infrared (NIR) imaging for detection of peritoneal metastases in patients undergoing cytoreductive surgery in epithelial ovarian cancer-A feasibility 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 |
RICHA GARG |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS NEW DELHI |
| Address |
MCH Block,department of Obstetrics and Gynaecology
AIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9799994698 |
| Fax |
|
| Email |
Richagarg1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Singhal |
| Designation |
Additional professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
MCH Block,Department of Obstetrics and Gynecology
AIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9818291001 |
| Fax |
|
| Email |
drseemasinghal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RICHA GARG |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS NEW DELHI |
| Address |
MCH Block,Department of obstetrics and gynaecology
AIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9799994698 |
| Fax |
|
| Email |
Richagarg1989@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS,New Delhi-110029,India |
|
|
Primary Sponsor
|
| Name |
AIIMS Delhi |
| Address |
AIIMS DELHI-110029,INDIA |
| 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 |
| DR RICHA GARG |
AIIMS DELHI |
MCH BLOCK,DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,AIIMS DELHI-110029,INDIA
New Delhi
DELHI |
9799994698
Richagarg1989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE,AIIMS DELHI-110029,INDIA |
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 |
Fluorescence guided surgery using Near-infrared (NIR) imaging using indocyanine green in patients undergoing cytoreductive surgery in epithelial ovarian cancer
|
After confirmation of the indication for cytoreductive surgery indocyanine green 0.25mg/kg injection will be given intravenously for once.
fluorescence imaging will be performed using a dedicated near-infrared (NIR) camera system.Time between administration of indocyanine green and imaging of the first lesion will be noted.The surgery will be then continued as per hospital protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients diagnosed with epithelial ovarian cancer with peritoneal metastases undergoing Primary or interval cytoreductive Surgery
2. Age≥ 18yearsold
3. Able to give informed consent.
4. ECOG Performance Score 0-2
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. History of allergy or hypersensitivity against ICG or lodine compounds.
2. Pregnancy and lactation.
3. Prior and current history of Bevacizumab administration.
4. Mucinous Histology.
5. ECOG Performance score 3-4
6. Surgically not meeting resectablity criteria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Concordance between fluorescent signal-detected peritoneal metastases and histopathology assessment |
4 WEEKS OF SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Concordance between fluorescent signal-detected lymph nodes and residual and histopathology assessment |
24 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| 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="11"
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
|
Near-infrared fluorescence imaging using indocyanine green can assist in intraoperative detection of ovarian cancer metastases by detection of additional peritoneal metastatic lesions that are not detected either by the naked eye or by palpation and thus help in achieving complete cytoreduction. It would also allow discrimination of malignant from benign residual scar tissue with its fluorescent activity, in patients treated with neoadjuvant chemotherapy.
|