Status:
COMPLETED
Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief 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 ...
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 trea...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03297489
Start Date
November 6 2017
End Date
February 15 2021
Last Update
October 6 2021
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263