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

Prostate Adenocarcinoma Clinical Trial

— PCAPETMR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03451812
• Other study ID #: 105-6435C
• Secondary ID: 104-4855A
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2019
• Source: Chang Gung Memorial Hospital
• Contact: Gigin Lin, MD, PhD
• Phone: 886-3281200
• Email: giginlin[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms

Locations

Country	Name	City	State
Taiwan	Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital	Guishan	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Accuracy	sensitivity, specificity, accuracy	1 year