CClinicalTrials.gg
Sign In
Status unknownNCT03451812PCAPETMRUpdated Aug 8, 2019

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

An observational study in Prostate Adenocarcinoma, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to male participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-08-08.

Sponsored by Chang Gung Memorial Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
120
Ages
40 Years to 85 Years
Sex
Male
01

Study 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.
Read the 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.

02

Conditions studied

  • Prostate Adenocarcinoma

Browse trials for

Keywords

  • prostate cancer
  • metabolomics
  • molecular imaging
  • PET
  • MRI
  • 11C-choline tracer
03

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients in a tertiary referral center.

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

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. Diagnostic Accuracy

    sensitivity, specificity, accuracy

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
    Guishan, Taoyuan 333, Taiwan
    Recruiting
07

Registry details

Key details

Study ID
NCT03451812
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Gigin Lin (Associate Professor, Chang Gung Memorial Hospital) — Principal investigator
First posted
Mar 2, 2018
Start date
Jan 1, 2017
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Aug 8, 2019

Study contacts

Gigin Lin, MD, PhD
Contact
giginlin@cgmh.org.tw
886-3281200 ext. 2575
Gigin Lin, MD, PhD
principal investigator · Medical Imaging and Intervention, Chang Gung Memorial Hospital

Oversight

FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Prostatic Neoplasms→

Other studies from this sponsor

Chang Gung Memorial Hospital

Start the discussion