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

Prostate Cancer Recurrent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01938339
• Other study ID #: PETMR-Prostate
• Status: Recruiting
• Phase: N/A
• First received: September 2, 2013
• Last updated: December 3, 2013
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: Jeong Yeon Cho, MD
• Phone: 82-2-2072-3074
• Email: radjycho[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Prostate Cancer Recurrent
• Prostatic Neoplasms
• Stage II Prostate Carcinoma
• Stage III Prostate Carcinoma

Intervention

Device:
• PET/MR
Multi-radiotracer PET/MR will be performed in patients with primary and recurrent prostate cancer

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of PET/MR predicting localization and staging of prostate cancer	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	No
Secondary	accuracy of early detection and localization of recurrent prostate cancer	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	No