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Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer

NCT02260817 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2019-12-17

Study results available
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Summary

This Phase 3 study will target approximately 100 men over age 18 who have a biochemical relapse or other evidence of relapse of prostate cancer after primary treatment.

The purpose of this study is to:

A. Provide expanded access the drug 11C-choline.

B. Determine the performance characteristics (sensitivity, specificity, positive predictive value, negative predictive value) of 11C-choline PET/Computed Tomography (CT) and PET/Magnetic Resonance Imaging (MRI) in the detection of metastatic prostate cancer in patients with biochemical relapse of prostate cancer after primary treatment in a prospective manner.

C. Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT and PET/MRI positive patients through a prospective study.

D. Determine factors that predict a confirmed positive 11C-choline PET/CT and PET/MRI using a multivariable analysis of clinical and pathologic data collected prospectively.

E. Compare the individual performance characteristics of 11C-choline PET/CT and 11C-choline PET/MRI and the combination of 11C-choline PET/CT and PET/MRI

Study Protocol:

1. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.
2. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer.
3. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer.
4. Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed with biopsy or surgical pathology when possible, or by response to treatment on subsequent imaging.
5. Rates of confirmed metastasis between conventional CT and MRI images will be compared with the 11C-choline PET CT and MRI images.
6. Upon conclusion of each imaging protocol, the referring physician will receive written documentation of the results. At this time, the patient will be considered off study and no further follow up is required.

Conditions

Interventions

DRUG

11C-choline Injection

1. Choline C11 Injection for PET/CT Imaging Protocol: * 15 - millicuries (mCi) 11C-choline IV Injection * PET images skull base to mid thigh with 3 min per bed position * Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol * Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: * No IV contrast * High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs * Fusion of coronal and PET images

Sponsors & Collaborators

  • Global Isotopes, LLC d/b/a Zevacor Molecular

    lead INDUSTRY

Principal Investigators

  • Thomas H Tarter, M.D, Ph.D · Decatur Memorial Hospital

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
2014-10-31
Primary Completion
2016-06-30
Completion
2018-06-30
FDA Drug
Yes

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 NCT02260817 on ClinicalTrials.gov