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

• Conditions: Prostate Adenocarcinoma

• Registration Number: NCT03451812
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-03-02
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-08
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy	1 year	sensitivity, specificity, accuracy

Trial Locations

Locations (1)

Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital; 🇨🇳 Guishan, Taoyuan, Taiwan