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esting a Real-Time Dye Imaging Technique to Find and Remove Hidden Cancer Spots During Surgery in Women with Advanced Ovarian Cancer

Performance Evaluation of Real-time Fluorescence-guided Resection of Peritoneal Metastases in Ovarian Cancer USing IndoCyanine Green during Interval Cytoreductive Surgery (FOCUS-ICG) - FOCUS ICG

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095889
Enrollment
56
Registered
2025-10-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C56- Malignant neoplasm of ovary Health Condition 2: C569- Malignant neoplasm of unspecifiedovary Health Condition 3: C569- Malignant neoplasm of unspecifiedovary Health Condition 4: C00-D49- Neoplasms

Interventions

Intervention1: 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

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Detection rate will be calculated based on intraoperative findings and histopathological reports within first 6 months of follow up—

Secondary

MeasureTime frame
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)Timepoint: At 6 months & 1 year & 2 year (beyond thesis period)—

Countries

India

Contacts

Public ContactDr Sampada Vivek Joshi

All India Institute Of Medical Sciences- Jodhpur

nivsha1985@gmail.com9657541321

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026