Molecular PET/MR Imaging in Vivo Validation of Biomarker... | NCT03451812

Studies
Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer

NCT03451812

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

Aug 8, 2019Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Prostate Adenocarcinoma

Interventions

Not provided

Countries

Taiwan

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

ID	Type	Description	Link
104-4855A	Other Identifier	CGMH

Status Module

Record Verification Date

Aug 2019

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

Jan 1, 2017Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Feb 26, 2018

First Submission Date that Met QC Criteria

Feb 26, 2018

First Posted Date

Mar 2, 2018Actual

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

Aug 6, 2019

Last Update Posted Date

Aug 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

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

Primary objective:

To correlate the blood/urine metabolomic biomarkers with PET/MR imaging.

Secondary objectives:

To evaluate the sensitivity and specificity of the PET/MR in diagnosis of prostate cancer.
To examine the diagnostic performance among subgroups of defined high-risk and low-risk subjects.
To interrogate the metabolomic alterations with the molecular PET/MR to develop workable panel biomarkers.

Detailed Description

According to 2015 National Comprehensive Cancer Network (NCCN) guideline, medical imaging plays important roles for detection and staging for PCa, in addition to blood or urine biomarkers. Although there are a number of very different diagnostic imaging methods, e.g. transrectal ultrasound (TRUS), computed tomography (CT), magnetic resonance (MR) imaging and spectroscopy, or 18F-FDG positron emission tomography (PET), none of these have gained a dominant role as the optimum method for all clinical scenarios.The recently added armamentarium, PET/MR, might improve diagnosis in this regard.

Therefore, we conduct this trial to identify the ability of [11C]Choline PET/MR to evaluate the patients with prostate cancer, especially under the circumstance of elevated PSA level.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
prostate cancer		The newly diagnostic number for the high-risk PCa patients in our hospital annually is ~70, it is clinically feasible to recruit 40 patients a year since the study begins. The study could be completed in 3 years with 120 cases.

Interventions

Not provided

Measure	Description	Time Frame
Diagnostic Accuracy	sensitivity, specificity, accuracy	1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males
40-85 years of age
Patients with a biopsy-proven or clinically highly suspected prostate adenocarcinoma, or benign prostatic hyperplasia
Able to tolerate [11C]Choline PET scan and MRI scan
Written informed consent from the patient

Exclusion Criteria:

Acute prostatitis or non-urologic bacterial infection requiring medical treatment within the last 3 months.
History of AIDS in the period prior to the screening.3
Contraindications to [11C]Choline PET/MR scans
1. Surgical implants including pacemaker implants, cochlear implants, dentures held in place by magnets imbedded in the gums and aneurysm clips except those inserted at CGMH
2. Metallic prosthesis of the hip or pelvic region
3. Renal function impairment with estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2
4. Claustrophobia
5. Medical drugs with choline
6. Previous allergy to carbon-labeled radionuclide
Active other malignancy within the last 2 years
Subject which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety.
Prisoners or patients with mental illness

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients in a tertiary referral center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gigin Lin, MD, PhD	Contact	886-3281200	2575	giginlin@cgmh.org.tw

Overall Officials

Name	Affiliation	Role
Gigin Lin, MD, PhD	Medical Imaging and Intervention, Chang Gung Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital	Recruiting	Guishan	Taoyuan	333	Taiwan

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