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

NCT ID: NCT01938339

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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

Conditions

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Prostate Cancer Recurrent Stage II Prostate Carcinoma Stage III Prostate Carcinoma

Keywords

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prostate cancer MRI PET

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET/MR

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

Group Type EXPERIMENTAL

PET/MR

Intervention Type DEVICE

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

Interventions

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PET/MR

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

Intervention Type DEVICE

Other Intervention Names

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Biograph mMR, Siemens Healthcare

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeong Yeon Cho, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jeong Yeon Cho, MD

Role: CONTACT

Phone: 82-2-2072-3074

Email: [email protected]

Sang Youn Kim, MD

Role: CONTACT

Phone: 82-2-2072-3321

Email: [email protected]

Facility Contacts

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Hyeon Jin Kim, RN

Role: primary

Other Identifiers

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PETMR-Prostate

Identifier Type: -

Identifier Source: org_study_id