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GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer

NCT01176513 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-02-14

Study results available
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Summary

Background:

\- GE-148 (18F) is a new drug that is designed to attach to prostate cancer cells. Researchers are interested in combining the drug with a small amount of radioactive material to allow prostate cancer lesions to appear more clearly on imaging scans. Researchers are also interested in determining whether the combination can help make cancer cells in pelvic lymph nodes easier to detect through imaging studies. GE-148 (18F) will be used to examine individuals who are scheduled to have surgery on their prostate cancer.

Objectives:

\- To evaluate the effectiveness of GE-148 (18F) in detecting prostate cancer and cancer cells in pelvic lymph nodes using positron emission tomography and magnetic resonance imaging scanning.

Eligibility:

\- Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled to have prostate removal surgery.

Design:

* Participants will be screened with a physical examination, medical history, blood tests, and imaging studies.
* Participants will have magnetic resonance imaging (MRI) and positron emission tomography (PET) scans with GE-148 (18F) prior to their scheduled surgery. The MRI and PET scans may be performed on the same day or on different days, depending on the schedule set by the study researchers.
* Tissue samples taken during prostate removal surgery, including prostate tissue and pelvic lymph nodes, will be collected for further study of the effectiveness of GE-148 (18F).

Conditions

Interventions

DRUG

GE-148 (18F)

All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Paul Gordon, PhD · GE Healthcare

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01176513 on ClinicalTrials.gov