Primary Peritoneal Carcinoma Clinical Trial
Official title:
A Pilot Study of Feasibility of Performing Intravital Microscopy in Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Verified date | October 2021 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | February 15, 2021 |
Est. primary completion date | February 15, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fluorescein within the tumor vessels | Will visualize fluorescein within the tumor vessels. | Up to 2 years | |
Primary | Identification of tumor vessels | Will identify tumor vessels. | Up to 2 years | |
Primary | Tumor vessel diameter | Will measure tumor vessel diameters. | Up to 2 years | |
Primary | Vessel density | Will determine vessel density per 10 x field. | Up to 2 years | |
Secondary | Blood flow velocity of the tumor vessels | Will assess the ability to measure the blood flow velocity of the tumor vessels. | Up to 2 years | |
Secondary | Tissue penetration of fluorescein | Will measure tissue penetration of fluorescein as a marker of tumor vessel permeability. | Up to 2 years |
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