Clinical trial · Interventional
ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
NCT04051502CI-TRIAL-00099105completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out how well ovarian sentinel lymph nodes (SLNs) can be identified with indocyanine green (ICG) dye during risk-reducing ovarian surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adnexal Mass | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Method 1: Indocyanine green dye | Drug | — | UNRESOLVED |
| Method 2: Indocyanine green dye | Drug | — | UNRESOLVED |
| Method 3: Indocyanine green dye | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- First group of 10 participants enrolled
- interventionNames
- Drug: Method 1: Indocyanine green dye
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Second group of 10 participants enrolled
- interventionNames
- Drug: Method 2: Indocyanine green dye
- type
- EXPERIMENTAL
- label
- Group 3
- description
- Third group of 10 participants enrolled
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women undergoing surgery with the Gynecology Service at MSK. * Women undergoing surgery for an adnexal mass without pre-operative suspicion of high stage disease, with or without a hysterectomy °For this protocol, "suspected high stage disease" will be defined as any patient with radiologic or clinical evidence of ovarian cancer which has spread outside of the ovary. Thus, only patients with an adnexal mass, or bilateral adnexal masses, are eligible. * Women in whom MIS surgery is converted to a laparotomy will not be excluded as both surgical approaches, MIS and open, will be utilized. * Women \>/= 18 years of age * Able to provide informed consent * Albumin levels within normal range Exclusion Criteria: * Current non-GYN primary malignancy * Prior or current history of uterine, cervical, peritoneal, or vulvovaginal malignancy * Ongoing anticancer therapy * Prior bilateral oophorectomy * Known severe anaphylactic iodide allergy * Known history of cirrhosis or other chronic liver disease, or women with hepatic dysfunction. * Elevated transaminases (ALT, AST) and/or Alk Phos will be evaluated by the treating physician on a case by case basis.
References
Publications (0)
Data not yet available
No reference posted for this study.