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

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ClinicalTrials.gov Identifier: NCT03451812
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Gigin Lin, Chang Gung Memorial Hospital

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.

Condition or disease
Prostate Adenocarcinoma

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.


Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Diagnostic Accuracy [ Time Frame: 1 year ]
    sensitivity, specificity, accuracy



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in a tertiary referral center.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451812


Contacts
Contact: Gigin Lin, MD, PhD 886-3281200 ext 2575 giginlin@cgmh.org.tw

Locations
Taiwan
Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital Recruiting
Guishan, Taoyuan, Taiwan, 333
Contact: Gigin Lin, MD, PhD    886-3281200 ext 2575    giginlin@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Gigin Lin, MD, PhD Medical Imaging and Intervention, Chang Gung Memorial Hospital

Responsible Party: Gigin Lin, Associate Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03451812     History of Changes
Other Study ID Numbers: 105-6435C
104-4855A ( Other Identifier: CGMH )
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gigin Lin, Chang Gung Memorial Hospital:
prostate cancer
metabolomics
molecular imaging
PET
MRI
11C-choline tracer

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type