Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03297489 |
Recruitment Status :
Completed
First Posted : September 29, 2017
Last Update Posted : October 6, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 |
Actual Primary Completion Date : | February 15, 2021 |
Actual Study Completion Date : | February 15, 2021 |

Arm | Intervention/treatment |
---|---|
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 Given IV
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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)

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 | |
Buffalo, New York, United States, 14263 |
Principal Investigator: | Emese Zsiros, MD | Roswell Park Cancer Institute |
Responsible Party: | Roswell Park Cancer Institute |
ClinicalTrials.gov Identifier: | NCT03297489 |
Other Study ID Numbers: |
I 43717 NCI-2017-01459 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) I 43717 ( Other Identifier: Roswell Park Cancer Institute ) |
First Posted: | September 29, 2017 Key Record Dates |
Last Update Posted: | October 6, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Ovarian Neoplasms Carcinoma, Ovarian Epithelial Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms |
Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |