Clinical trial NCT01938339: Development of Clinical Assessment Technique Using Multi-radiotracer PET/MR in Prostate Cancer
Official title: Development of Clinical Assessment Technique Using Multi-radiotracer PET/MR in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer Recurrent
Stage II Prostate Carcinoma
Stage III Prostate Carcinoma
Keywords: prostate cancer
MRI
PET
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

* 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 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

Primary outcomes:
measure: accuracy of PET/MR predicting localization and staging of prostate cancer
timeFrame: 1 week after radical prostatectomy
Secondary outcomes:
measure: accuracy of early detection and localization of recurrent prostate cancer
timeFrame: 1 week after PET/MR imaging
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Yeon Cho, MD
role: PRINCIPAL_INVESTIGATOR
References: