Development of Clinical Assessment Technique Using Multi-radiotracer PET/MR in Prostate Cancer

December 3, 2013 updated by: Seoul National University Hospital

To development of clinical assessment technique using multi-radiotracer positron emission tomography/magnetic resonance (PET/MR) in prostate cancer

  • to establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer
  • to establish the imaging biomarker using PET/MR for clinical assessment of prostate cancer and early detection of recurrent prostate cancer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer

  • Recruiting 30 patients with prostate cancer ahead to radical prostatectomy
  • PET/MR using 18F-choline with dedicated prostate MRI in all patients
  • PET/MR using 18fluoride(F)-fluorodeoxyglucose(FDG)in all patients after 2-7 days
  • PET/CT using 18F-FDG in all patient immediate after 18F-FDG PET/MR
  • outcome assessment: comparison of scan time, image quality, tumor detection rate, standardized uptake values of lesions
  • establishing optimal imaging technique for prostate PET/MR

To establish the imaging biomarker using PET/MR for clinical assessment of prostate cancer

  • comparison of findings on PET/MR, MRI and PET/CT with pathological mapping after radical prostatectomy
  • outcome assessment: accuracy of PET/MR for localization and staging of prostate cancer compared with MRI only and PET/CT only

To establish the imaging biomarker using PET/MR for early detection of recurrent prostate cancer

  • Recruiting 15 patients with recurrent prostate cancer treated by surgery, hormone, or radiation therapy
  • Recruiting 15 patients with treated prostate cancer without recurrence
  • PET/MR using 18F-choline with dedicated prostate MRI in all patients
  • PET/MR using 18F-FDG in all patients after 2-7 days
  • PET/CT using 18F-FDG in all patient immediate after 18F-FDG PET/MR
  • comparison of findings on PET/MR, MRI, and PET/CT with clinical data in two patient groups with or without recurrent prostate cancer
  • outcome assessment: accuracy of PET/MR for early detection and localization of recurrent prostate cancer compared with MRI only and PET/CT only

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Sub-Investigator:
          • Jin Chul Paeng, MD
        • Sub-Investigator:
          • Gi Jeong Cheon, MD
        • Sub-Investigator:
          • Cheol Kwak, MD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • patient with prostate cancer before treatment
  • patient with prostate cancer treated
  • patient with prostate cancer recurrent

Exclusion Criteria:

  • patient with contraindication for MRI
  • Patient with severe renal impairment

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: PET/MR
Multi-radiotracer PET/MR will be performed to compare the accuracy of tumor detection in patient with primary prostate cancer
Device: PET/MR
Multi-radiotracer PET/MR will be performed in patients with primary and recurrent prostate cancer
Other Names:
  • Biograph mMR, Siemens Healthcare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of PET/MR predicting localization and staging of prostate cancer
Time Frame: 1 week after radical prostatectomy
analysis of accuracy of PET/MR predicting localization and staging of prostate cancer by comparison of PET/MR findings with pathological mapping images after radical prostatectomy
1 week after radical prostatectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of early detection and localization of recurrent prostate cancer
Time Frame: 1 week after PET/MR imaging
accuracy of PET/MR for early detection and localization of recurrence by comparison of PET/MR findings with clinical data in two groups of patients with or without recurrent prostate cancer
1 week after PET/MR imaging

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jeong Yeon Cho, MD, Seoul National University Hospital

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

May 1, 2012

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

December 5, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PETMR-Prostate

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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