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

Primary Purpose

Prostate Cancer Recurrent, Stage II Prostate Carcinoma, Stage III Prostate Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

PET/MR

About this trial

This is an interventional diagnostic trial for Prostate Cancer Recurrent focused on measuring prostate cancer, MRI, PET

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/MR

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01938339

First Posted

September 2, 2013

Last Updated

December 3, 2013

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01938339

Brief Title

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

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

April 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer Recurrent, Stage II Prostate Carcinoma, Stage III Prostate Carcinoma

Keywords

prostate cancer, MRI, PET

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PET/MR

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

PET/MR

Other Intervention Name(s)

Biograph mMR, Siemens Healthcare

Intervention Description

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

Primary Outcome Measure Information:

Title

accuracy of PET/MR predicting localization and staging of prostate cancer

Description

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

Time Frame

1 week after radical prostatectomy

Secondary Outcome Measure Information:

Title

accuracy of early detection and localization of recurrent prostate cancer

Description

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

Time Frame

1 week after PET/MR imaging

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeong Yeon Cho, MD

Phone

82-2-2072-3074

radjycho@snu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Sang Youn Kim, MD

Phone

82-2-2072-3321

iwishluv@empas.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeong Yeon Cho, MD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hyeon Jin Kim, RN

Phone

82-10-9944-2569

onara53@naver.com

First Name & Middle Initial & Last Name & Degree

Jin Chul Paeng, MD

First Name & Middle Initial & Last Name & Degree

Gi Jeong Cheon, MD

First Name & Middle Initial & Last Name & Degree

Cheol Kwak, MD

12. IPD Sharing Statement

Learn more about this trial

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

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