Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI

January 19, 2021 updated by: Ming Yang, M.D., Mayo Clinic

Staging of Untreated Patients With Very High-risk and High-risk Prostate Carcinoma Utilizing Hybrid C11-choline PET/MR and Pelvic Multiparametric MRI for Personalized Precise Treatment: a Pilot Study

The purpose of this study is to find out if a PET/MR scan in combination with standard MRI and CT scans can improve the early detection and treatment of patients with prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

High risk prostate cancer patients will undergo C11-Choline PET/MR whole body fusion scan and pelvic mpMRI for accurate staging. The PET/MR imaging findings, including the primary lesion with the prostate bed and pelvic lymph nodes, will be correlated with the histopathologic result. Researchers aim to provide accurate one-stop shopping opportunity in diagnosis and staging of high risk prostate cancer using the C11-choline PET/MR scan.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

1. Untreated patients with high-risk and very high-risk prostate cancer, who require clinical pelvic mpMRI, CT, and bone scan as standard clinical care for diagnosis and management of prostate cancer.

Exclusion Criteria:

  1. Patients who already received primary treatment or neo-adjuvant therapy.
  2. Patients who refuse undergoing routine clinical imaging (i.e., pelvic mpMRI, CT, bone scan) for staging. Reimbursement of pelvic mpMRI in this study is denied. CT and bone scan may be done elsewhere outside of Mayo Clinic but should be of diagnostic quality. Research C-11 choline PET/MR will not substitute pelvic mpMRI, CT, or bone scan in this study.
  3. Patients cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm, involuntary movement [e.g., tremor, dystonia]).
  4. Patients have total hip arthroplasty (THA), which can cause substantial susceptibility artifact and degrade image quality of mpMRI.
  5. Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit.
  6. Patients have contraindication to gadolinium based MR contrast agents (e.g., renal failure, severe reaction to gadolinium based MR contrast agents). Epidermal growth factor receptor (eGFR) should be above 30 within 30 days the time of mpMRI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Risk Prostate Cancer Patients
Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI).
Drug: C-11 choline PET tracer
C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.
Other Names:
  • Choline C-11 Injection
Drug: Gadobutrol
Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.
Other Names:
  • Gadavist
Device: PET/MR scanner
C11-PET/MR and pelvic mpMRI scan for prostate cancer.
Other Names:
  • GE SIGNA 3T PET/MR scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake Value of C11-choline
Time Frame: Baseline
Measured by maximum standardized uptake value (SUVmax) of indexed lesions. SUV is calculated as ratio of concentration of tissue reactivity divided by dose at time of injection divided by body weight.
Baseline
Number of Lesions Showing C11-Choline Uptake
Time Frame: Baseline
Measured by the mean number of lesions to show C11-Choline uptake.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Ming Yang, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

January 23, 2020

Study Completion (Actual)

January 23, 2020

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-007897

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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