Prostate AdenocarcinomaPCAPETMRNCT03451812
Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer
An observational study of Prostate Adenocarcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients in a tertiary referral center.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
Guishan, Taoyuan, 333
Gigin Lin, MD, PhD, 886-3281200 ext. 2575, giginlin@cgmh.org.tw
About this study
Primary objective:
To correlate the blood/urine metabolomic biomarkers with PET/MR imaging.
Secondary objectives:
- To evaluate the sensitivity and specificity of the PET/MR in diagnosis of prostate cancer.
- To examine the diagnostic performance among subgroups of defined high-risk and low-risk subjects.
- 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.
- Conditions
- Prostate Adenocarcinoma
- Keywords
- prostate cancer, metabolomics, molecular imaging, PET, MRI, 11C-choline tracer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
sensitivity, specificity, accuracy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gigin Lin, Chang Gung Memorial Hospital
- Investigators
- Gigin Lin, MD, PhD, Principal investigator, Medical Imaging and Intervention, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451812
- Sponsor's protocol ID
- 105-6435C
- Other IDs
- 104-4855A
- Acronym
- PCAPETMR
- Status last verified
- Aug 2019
- First submitted
- 26 Feb 2018
- Last updated
- 8 Aug 2019
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer
- ClinicalTrials.gov ID
- NCT03451812
- Acronym / sponsor ID
- PCAPETMR / 105-6435C
- Conditions
- Prostate Adenocarcinoma
- Keywords
- prostate cancer, metabolomics, molecular imaging, PET, MRI, 11C-choline tracer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
To correlate the blood/urine metabolomic biomarkers with PET/MR imaging.
Secondary objectives:
- To evaluate the sensitivity and specificity of the PET/MR in diagnosis of prostate cancer.
- To examine the diagnostic performance among subgroups of defined high-risk and low-risk subjects.
- To interrogate the metabolomic alterations with the molecular PET/MR to develop workable panel biomarkers.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in a tertiary referral center.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy
Time frame: 1 year
sensitivity, specificity, accuracy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gigin Lin, MD, PhD principal investigator
Medical Imaging and Intervention, Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Adenocarcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gigin Lin, MD, PhD (886-3281200 ext. 2575, giginlin@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.