Trials / Completed
CompletedNCT03297489
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
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
PRIMARY OBJECTIVES: I. To determine the feasibility of performing intravital microscopy on accessible human ovarian, primary peritoneal and fallopian tube cancers during their standard course of treatment (i.e., surgical debulking). SECONDARY OBJECTIVES: I. To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein as a marker of tumor vessel permeability. OUTLINE: Patients receive fluorescein sodium injection intravenously (IV). Patients also undergo observation of primary and metastatic tumors via microscopy over 15-20 minutes during the course of standard of care surgery. After completion of study, patients are followed up for 30 days, at 1-3 weeks, and then up to 2 years.
Conditions
- Fallopian Tube Carcinoma
- Primary Peritoneal Carcinoma
- Stage I Ovarian Cancer
- Stage IA Ovarian Cancer
- Stage IB Ovarian Cancer
- Stage IC Ovarian Cancer
- Stage II Ovarian Cancer
- Stage IIA Ovarian Cancer
- Stage IIB Ovarian Cancer
- Stage IIC Ovarian Cancer
- Stage III Ovarian Cancer
- Stage IIIA Ovarian Cancer
- Stage IIIB Ovarian Cancer
- Stage IIIC Ovarian Cancer
- Stage IV Ovarian Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Diagnostic Microscopy | Undergo observation via intravital microscopy |
| DRUG | Fluorescein Sodium Injection | Given IV |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2017-11-06
- Primary completion
- 2021-02-15
- Completion
- 2021-02-15
- First posted
- 2017-09-29
- Last updated
- 2021-10-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03297489. Inclusion in this directory is not an endorsement.