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Clinical Trials/NCT01938339
NCT01938339UnknownNot Applicable

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

Seoul National University Hospital1 site in 1 country60 target enrollmentStarted: May 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
accuracy of PET/MR predicting localization and staging of prostate cancer

Study Overview

Brief Summary

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

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Sex
Male
Accepts Healthy Volunteers
No

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

Arms & Interventions

PET/MR

Experimental

Multi-radiotracer PET/MR will be performed to compare the accuracy of tumor detection in patient with primary prostate cancer

Intervention: PET/MR (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • accuracy of early detection and localization of recurrent prostate cancer(1 week after PET/MR imaging)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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