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

NCT ID: NCT03451812

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-12-31

Brief Summary

Primary objective:

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

Secondary objectives:

1. To evaluate the sensitivity and specificity of the PET/MR in diagnosis of prostate cancer.

2. To examine the diagnostic performance among subgroups of defined high-risk and low-risk subjects.

3. 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.

Conditions

Prostate Adenocarcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gigin Lin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gigin Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Imaging and Intervention, Chang Gung Memorial Hospital

Locations

Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital

Guishan, Taoyuan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Gigin Lin, MD, PhD

Role: CONTACT

giginlin@cgmh.org.tw

886-3281200 ext. 2575

Facility Contacts

Gigin Lin, MD, PhD

Role: primary

giginlin@cgmh.org.tw

886-3281200 ext. 2575

Other Identifiers

104-4855A

Identifier Type: OTHER

Identifier Source: secondary_id

105-6435C

Identifier Type: -

Identifier Source: org_study_id