Clinical trial NCT03451812: Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer
Official title: Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Adenocarcinoma
Keywords: prostate cancer
metabolomics
molecular imaging
PET
MRI
11C-choline tracer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in a tertiary referral center.

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.

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

Primary outcomes:
measure: Diagnostic Accuracy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guishan
country: Taiwan
facility: Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
state: Taoyuan
Study officials:
affiliation: Medical Imaging and Intervention, Chang Gung Memorial Hospital
name: Gigin Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: