Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
18

Inclusion Criteria

Suspicion of gynecological malignancy that requires a standard of care surgical resection in the operating room;
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
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
...
Suspicion of gynecological malignancy that requires a standard of care surgical resection in the operating room;
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
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
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),
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

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)
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)
Nursing female subjects
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

Summary

Conditions
  • Primary Peritoneal Carcinoma
  • Fallopian Tube Carcinoma
  • Stage I Ovarian Cancer
  • Stage IV Ovarian Cancer
  • Stage IA Ovarian Cancer
  • Stage IB Ovarian Cancer
  • Stage IC Ovarian Cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIIB Ovarian Cancer
  • Stage II Ovarian Cancer
  • Stage IIA Ovarian Cancer
  • Stage IIB Ovarian Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IIC Ovarian Cancer
  • Stage III Ovarian Cancer
Type
Interventional
Phase
Early Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only females

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 th...

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.

Inclusion Criteria

Suspicion of gynecological malignancy that requires a standard of care surgical resection in the operating room;
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
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
...
Suspicion of gynecological malignancy that requires a standard of care surgical resection in the operating room;
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
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
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),
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

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)
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)
Nursing female subjects
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

Locations

Buffalo, New York, 14263
Buffalo, New York, 14263

Tracking Information

NCT #
NCT03297489
Collaborators
Not Provided
Investigators
  • Principal Investigator: Emese Zsiros, MD Roswell Park Cancer Institute
  • Emese Zsiros, MD Roswell Park Cancer Institute