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Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand

NCT ID: NCT01511055

Last Updated: 2020-11-12

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-06-30

Brief Summary

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Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete surgical resection, also known as a R0 resection. At present, the ability to perform a complete resection with negative margins is limited by the surgeon's ability to palpate and visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and costs while maintaining or improving surgical and oncologic outcomes, the investigators must develop technologies that improve visualization of the primary tumor and occult metastases, real time, during surgery. Recent research has demonstrated that the use of fluorescent probes that recognize cancer specific antigens can be used for this purpose when visualized using a prototype near-infrared multispectral imaging system.

This investigation will determine if folate-FITC, a fluorescent probe that recognizes the folate receptor (present in \> 90% of ovarian cancers) can facilitate surgical resection and detect tumor nodules not visible to the naked eye.

Detailed Description

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Conditions

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Ovarian Cancer

Keywords

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Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Folate-FITC

Group Type EXPERIMENTAL

EC-17

Intervention Type DRUG

One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.

Interventions

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EC-17

One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.

Intervention Type DRUG

Other Intervention Names

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Folate-FITC

Eligibility Criteria

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Inclusion Criteria

Women who are:

* Diagnosed with or at high clinical suspicion of primary ovarian cancer by either radiologic imaging or physical examination or biopsy or serum tumor markers
* Scheduled to undergo surgical cytoreduction via laparotomy
* At least 18 years of age
* Capable and willing to provide informed consent

Exclusion Criteria

Women with:

* Known sarcomatous histologies
* Recurrent ovarian cancer
* Planned surgical approach via laparoscopy or robotic surgery
* A history of anaphylactic reactions to Folate-FITC or insects
* Inability or unwillingness to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Sean C Dowdy, MD

Associate Professor - Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sean C Dowdy, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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11-002980

Identifier Type: -

Identifier Source: org_study_id