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

NCT03451812 | Unknown

• 2 other identifiers: 105-6435C104-4855A
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: To correlate the blood/urine metabolomic biomarkers with PET/MR imaging. Secondary objectives:

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

Conditions

Prostate Adenocarcinoma

Keywords

prostate cancer; metabolomics; molecular imaging; PET; MRI; 11C-choline tracer

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy

  sensitivity, specificity, accuracy

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in a tertiary referral center.

You may qualify if:

• Males
• 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

You may not qualify if:

• 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
• 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
• Metallic prosthesis of the hip or pelvic region
• Renal function impairment with estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2
• Claustrophobia
• Medical drugs with choline
• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital

Guishan, Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Gigin Lin, MD, PhD

  Medical Imaging and Intervention, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gigin Lin, MD, PhD

CONTACT

886-3281200; giginlin@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 8, 2019

Record last verified: 2019-08

Locations

TW (1)