Clinical trial · Interventional
ICG to Assess Ovarian Perfusion
Intraoperative Use of Intravenous Indocyanine Green (ICG) to Assess Ovarian Perfusion Using Infrared Imaging: A Feasibility Pilot Study
NCT03927651CI-TRIAL-00065765completedEarly 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)
To assess the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries during gynecologic surgery
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cyst | — | UNRESOLVED | — |
| Endometriosis | — | UNRESOLVED | — |
| Fibroid Uterus | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Uterine Adenomyosis | — | UNRESOLVED | — |
| Uterine Cyst | — | UNRESOLVED | — |
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Uterus Myoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Administration of ICG
- description
- ICG will be injected intravenously to assess ovarian perfusion in the presence or absence (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the ICG. The extent of perfusion will be determined using digital imaging software. ICG will be stored at the NM Investigational Pharmacy and administered intravenously by the anesthesiologist at the direction of the surgeon during surgical procedure.
- interventionNames
- Drug: ICG
Primary outcomes (1)
- measure
- Assessment of ovarian perfusion after ICG administration via fluorescent imaging
- timeFrame
- 2 years
- description
- The investigators will be assessing the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries by imaging. During surgery ICG will be administered intravenously via a peripheral or central line at the direction of the surgeon by the anesthesiologist. The injected amount will be a 3 mL solution of reconstituted ICG that contains a 7.5 mg dose of ICG. This will be followed by a 10 mL bolus of normal saline for injection per the manufacturer's recommendation. The total dose of dye injected should not exceed 2 mg/kg. Visibility of the ICG fluorescence should occur within 1-2 minutes with a duration of 20-120 minutes.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Patients attending a preoperative visit at the Center for Comprehensive Gynecology who will undergo surgery. Exclusion Criteria: * Not able to comprehend and sign a written consent * Patients with a history of allergy to iodides * Patients history of renal failure or uremia, and those on dialysis
References
Publications (0)
Data not yet available
No reference posted for this study.