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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01938339
First received: September 2, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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

Condition Intervention
Prostate Cancer Recurrent
Stage II Prostate Carcinoma
Stage III Prostate Carcinoma
Device: PET/MR

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Development of Clinical Assessment Technique Using Multi-radiotracer PET/MR in Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • accuracy of PET/MR predicting localization and staging of prostate cancer [ Time Frame: 1 week after radical prostatectomy ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • accuracy of early detection and localization of recurrent prostate cancer [ Time Frame: 1 week after PET/MR imaging ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Biograph mMR, Siemens Healthcare

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
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938339

Contacts
Contact: Jeong Yeon Cho, MD 82-2-2072-3074 radjycho@snu.ac.kr
Contact: Sang Youn Kim, MD 82-2-2072-3321 iwishluv@empas.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Hyeon Jin Kim, RN    82-10-9944-2569    onara53@naver.com   
Sub-Investigator: Jin Chul Paeng, MD         
Sub-Investigator: Gi Jeong Cheon, MD         
Sub-Investigator: Cheol Kwak, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jeong Yeon Cho, MD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01938339     History of Changes
Other Study ID Numbers: PETMR-Prostate
Study First Received: September 2, 2013
Last Updated: December 3, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
prostate cancer
MRI
PET

Additional relevant MeSH terms:
Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014