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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01459 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 43717 | Other Identifier | Roswell Park Cancer Institute |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (intravital microscopy) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Microscopy | Procedure | Undergo observation via intravital microscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fluorescein within the tumor vessels | Will visualize fluorescein within the tumor vessels. | Up to 2 years |
| Identification of tumor vessels | Will identify tumor vessels. | Up to 2 years |
| Tumor vessel diameter | Will measure tumor vessel diameters. | Up to 2 years |
| Vessel density | Will determine vessel density per 10 x field. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Tissue penetration of fluorescein | Will measure tissue penetration of fluorescein as a marker of tumor vessel permeability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emese Zsiros, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Fluorescein Sodium Injection | Drug | Given IV |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Up to 2 years |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D019793 | Fluorescein |
| D005452 | Fluoresceins |
| ID | Term |
|---|---|
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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