Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
18

Summary

Conditions
  • Primary Peritoneal Carcinoma
  • Fallopian Tube Carcinoma
  • Stage IV Ovarian Cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIIB Ovarian Cancer
  • Stage I Ovarian Cancer
  • Stage IA Ovarian Cancer
  • Stage IIIC 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
Type
Interventional
Phase
Early Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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.

Tracking Information

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