Clinical trial · Interventional
Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer
A Pilot Study of Feasibility of Performing Intravital Microscopy in Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
- 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)
This pilot clinical trial studies how well intravital microscopy works in evaluating patients with primary peritoneal, fallopian tube, or stage IA-IV ovarian cancer. Intravital microscopic evaluation of tumor blood vessels, blood flow, immune cell interactions, and drug uptake may be eventually visualized and may lead to valuable prognostic information.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IA Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IC Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Ovarian Cancer |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Microscopy | Procedure | — | UNRESOLVED |
| Fluorescein Sodium Injection | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (intravital microscopy)
- description
- Patients receive fluorescein sodium injection IV. Patients also undergo observation of primary and metastatic tumors via microscopy over 15-20 minutes during the course of standard of care surgery.
- interventionNames
- Procedure: Diagnostic Microscopy
- Drug: Fluorescein Sodium Injection
- Other: Laboratory Biomarker Analysis
Primary outcomes (4)
- measure
- Fluorescein within the tumor vessels
- timeFrame
- Up to 2 years
- description
- Will visualize fluorescein within the tumor vessels.
- measure
- Identification of tumor vessels
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Suspicion of gynecological malignancy that requires a standard of care surgical resection in the operating room; * Have measurable lesion in the pelvis or abdomen, at a minimum of 0.5 cm in diameter on standard of care pre operative imaging studies (CT, MRI or PET scan), * Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure * Serum Creatinine \<= 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL/min for participant with creatinine levels \> 1.5 X institutional ULN (using Cockcroft-Gault Equation), GFR can also be used in place of creatinine or CrCl. Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Any known allergy or prior reaction to fluorescein * Nursing female subjects * Liver dysfunction; normal liver function defined as total bilirubin within normal institutional limits and aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal * Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography (EKG), chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)
References
Publications (0)
Data not yet available