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

Seoul National University

Status: Unknown

Conditions: Stage II Prostate Carcinoma; Prostate Cancer Recurrent; Stage III Prostate Carcinoma

Treatments: Device: PET/MR

Study type: Interventional

Funder types: Other

Identifiers

NCT01938339

PETMR-Prostate

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

PET/MR

Experimental group

Description:

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

Treatment:

Device: PET/MR