Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03297489|
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : June 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Procedure: Diagnostic Microscopy Drug: Fluorescein Sodium Injection Other: Laboratory Biomarker Analysis||Early Phase 1|
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).
I. To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein as a marker of tumor vessel permeability.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Feasibility of Performing Intravital Microscopy in Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer|
|Actual Study Start Date :||November 6, 2017|
|Estimated Primary Completion Date :||May 15, 2019|
|Estimated Study Completion Date :||May 15, 2020|
Experimental: Diagnostic (intravital microscopy)
Patients receive fluorescein sodium injection IV. Patients also undergo observation of primary and metastatic tumors via microscopy over 15-20 minutes during the course of standard of care surgery.
Procedure: Diagnostic Microscopy
Undergo observation via intravital microscopy
Drug: Fluorescein Sodium Injection
Other: Laboratory Biomarker Analysis
- Fluorescein within the tumor vessels [ Time Frame: Up to 2 years ]Will visualize fluorescein within the tumor vessels.
- Identification of tumor vessels [ Time Frame: Up to 2 years ]Will identify tumor vessels.
- Tumor vessel diameter [ Time Frame: Up to 2 years ]Will measure tumor vessel diameters.
- Vessel density [ Time Frame: Up to 2 years ]Will determine vessel density per 10 x field.
- Blood flow velocity of the tumor vessels [ Time Frame: Up to 2 years ]Will assess the ability to measure the blood flow velocity of the tumor vessels.
- Tissue penetration of fluorescein [ Time Frame: Up to 2 years ]Will measure tissue penetration of fluorescein as a marker of tumor vessel permeability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297489
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: ASK RPCI 877-275-7724 ASKRPCI@roswellpark.org|
|Principal Investigator: Kunle Odunsi|
|Principal Investigator:||Kunle Odunsi||Roswell Park Cancer Institute|