Clinical trial · Observational
Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer
NCT03451812CI-TRIAL-00039964PCAPETMRunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- prostate cancer
- description
- 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.
Primary outcomes (1)
- measure
- Diagnostic Accuracy
- timeFrame
- 1 year
- description
- sensitivity, specificity, accuracy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.