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

NCT01511055 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-11-12

Study results available
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Summary

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.

Conditions

Interventions

DRUG

EC-17

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

Sponsors & Collaborators

Principal Investigators

  • Sean C Dowdy, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-06-30
Completion
2014-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01511055 on ClinicalTrials.gov