Development of Clinical Assessment Technique Using Multi-... | NCT01938339

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

NCT01938339

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Dec 5, 2013Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Prostate Cancer Recurrent
Stage II Prostate Carcinoma
Stage III Prostate Carcinoma

Interventions

PET/MR

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Apr 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Sep 2, 2013

First Submission Date that Met QC Criteria

Sep 4, 2013

First Posted Date

Sep 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2013

Last Update Posted Date

Dec 5, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PET/MR	Experimental	Multi-radiotracer PET/MR will be performed to compare the accuracy of tumor detection in patient with primary prostate cancer	Device: PET/MR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET/MR	Device	Multi-radiotracer PET/MR will be performed in patients with primary and recurrent prostate cancer	PET/MR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeong Yeon Cho, MD	Contact	82-2-2072-3074		radjycho@snu.ac.kr
Sang Youn Kim, MD	Contact	82-2-2072-3321		iwishluv@empas.com

Overall Officials

Name	Affiliation	Role
Jeong Yeon Cho, MD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

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