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Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02260817
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Global Isotopes, LLC d/b/a Zevacor Molecular

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Prostate Cancer Drug: 11C-choline Injection Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Expanded Access to 11C Choline PET/CT and 11C Choline PET/MR for Staging of Recurrent Prostate Cancer With Comparison Study of CT and MR Modalities
Study Start Date : October 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 11C-choline for Staging of Recurrent Prostate Cancer

The key objective of this study is to provide expanded access to this drug product as currently defined under the reference listed drug as an investigational drug in geographical service areas where 11C-choline injection is not available.

Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm of the study will not be further analyzed beyond that need for clinical diagnosis.

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
Other Name: CCH Injection, C11 Choline Injection

Experimental: 11C-choline Comparison Study of CT and MR Modalities

11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.

Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images

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
Other Name: CCH Injection, C11 Choline Injection




Primary Outcome Measures :
  1. Evidence of Metastatic Prostate Cancer [ Time Frame: After 11C-choline PET CT scan and MRI scan ]
    The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. The 11C-choline PET CT scan and MRI scan will be evaluated for evidence of metastatic prostate cancer.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. For biochemical relapse after primary treatment

    1. PSA > 0.2 ng/ml after radical prostatectomy confirmed at that level or higher on a subsequent test 3 months later
    2. PSA increase >2 ng/ml from nadir following radiation therapy
    3. PSA increase >2 ng/ml from nadir following radiation therapy plus androgen deprivation therapy with nadir defined with normalized testosterone level
    4. Two consecutive PSA increases from nadir level after androgen blockade or androgen suppression therapy
  2. Kidney function with GFR > 60 mL/sec/1.73m2 and Creatinine < 1.7mg, collected within 90 days of planned scan

    1. if GFR is > or equal to 60 mL/sec/1.73m2, PET/CT will be completed with contrast
    2. if GFR is < 60 mL/sec/1.73m2, PET/CT will be completed without contrast
    3. if Creatinine is > than 1.7 mg, Radiology will follow ACR recommendations as outlined in department policy.
  3. No known allergy to iodinated radiologic contrast media
  4. Able to have MRI based on screening evaluation. If patient is found to be MRI incompatible, the 11C-choline PET/MRI portion of the study will not be completed. Please see the provided contact numbers for further options.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Exclusion Criteria:

  1. ECOG Performance Status > 2.
  2. Concurrent malignancy, i.e. colon cancer.
  3. Treatment for another malignancy except superficial skin cancer within 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260817


Locations
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United States, Illinois
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Sponsors and Collaborators
Global Isotopes, LLC d/b/a Zevacor Molecular
Investigators
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Principal Investigator: Thomas H Tarter, M.D, Ph.D Decatur Memorial Hospital

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Responsible Party: Global Isotopes, LLC d/b/a Zevacor Molecular
ClinicalTrials.gov Identifier: NCT02260817     History of Changes
Other Study ID Numbers: ZM-CCH-40-PTL0114
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Global Isotopes, LLC d/b/a Zevacor Molecular:
Prostate Cancer
11C Choline
PET Imaging

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents