Prostate Cancer RecurrentNCT01938339
Development of Clinical Assessment Technique Using Multi-radiotracer PET/MR in Prostate Cancer
A study testing PET/MR in people with Prostate Cancer Recurrent and Stage II Prostate Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To development of clinical assessment technique using multi-radiotracer positron emission tomography/magnetic resonance (PET/MR) in prostate cancer to establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer to establish the imaging biomarker using PET/MR for clinical… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer Recurrent, Stage II Prostate Carcinoma, Stage III Prostate Carcinoma
- What is being tested?
- PET/MR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Dec 2014
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient with prostate cancer before treatment
- patient with prostate cancer treated
- patient with prostate cancer recurrent
Who cannot join
- patient with contraindication for MRI
- Patient with severe renal impairment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Hyeon Jin Kim, RN, 82-10-9944-2569, onara53@naver.com
Jin Chul Paeng, MD
About this study
To development of clinical assessment technique using multi-radiotracer positron emission tomography/magnetic resonance (PET/MR) in prostate cancer
- to establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer
- to establish the imaging biomarker using PET/MR for clinical assessment of prostate cancer and early detection of recurrent prostate cancer
Read the detailed description
To establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer
- Recruiting 30 patients with prostate cancer ahead to radical prostatectomy
- PET/MR using 18F-choline with dedicated prostate MRI in all patients
- PET/MR using 18fluoride(F)-fluorodeoxyglucose(FDG)in all patients after 2-7 days
- PET/CT using 18F-FDG in all patient immediate after 18F-FDG PET/MR
- outcome assessment: comparison of scan time, image quality, tumor detection rate, standardized uptake values of lesions
- establishing optimal imaging technique for prostate PET/MR
To establish the imaging biomarker using PET/MR for clinical assessment of prostate cancer
- comparison of findings on PET/MR, MRI and PET/CT with pathological mapping after radical prostatectomy
- outcome assessment: accuracy of PET/MR for localization and staging of prostate cancer compared with MRI only and PET/CT only
To establish the imaging biomarker using PET/MR for early detection of recurrent prostate cancer
- Recruiting 15 patients with recurrent prostate cancer treated by surgery, hormone, or radiation therapy
- Recruiting 15 patients with treated prostate cancer without recurrence
- PET/MR using 18F-choline with dedicated prostate MRI in all patients
- PET/MR using 18F-FDG in all patients after 2-7 days
- PET/CT using 18F-FDG in all patient immediate after 18F-FDG PET/MR
- comparison of findings on PET/MR, MRI, and PET/CT with clinical data in two patient groups with or without recurrent prostate cancer
- outcome assessment: accuracy of PET/MR for early detection and localization of recurrent prostate cancer compared with MRI only and PET/CT only
- Being tested
- PET/MR
- Keywords
- prostate cancer, MRI, PET
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRDevice
Also called Biograph mMR, Siemens Healthcare
Multi-radiotracer PET/MR will be performed in patients with primary and recurrent prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| PET/MR | Experimental | Multi-radiotracer PET/MR will be performed to compare the accuracy of tumor detection in patient with primary prostate cancer Receives: Device: PET/MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of PET/MR predicting localization and staging of prostate cancer
analysis of accuracy of PET/MR predicting localization and staging of prostate cancer by comparison of PET/MR findings with pathological mapping images after radical prostatectomy
Measured: 1 week after radical prostatectomy
Secondary outcomes (1)
accuracy of early detection and localization of recurrent prostate cancer
accuracy of PET/MR for early detection and localization of recurrence by comparison of PET/MR findings with clinical data in two groups of patients with or without recurrent prostate cancer
Measured: 1 week after PET/MR imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startMay 2012
- Primary completionApr 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeong Yeon Cho, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938339
- Sponsor's protocol ID
- PETMR-Prostate
- Status last verified
- Dec 2013
- First submitted
- 2 Sep 2013
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Clinical Assessment Technique Using Multi-radiotracer PET/MR in Prostate Cancer
- ClinicalTrials.gov ID
- NCT01938339
- Acronym / sponsor ID
- PETMR-Prostate
- Keywords
- prostate cancer, MRI, PET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 10 Sep 2013 (estimated)
- 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.
To development of clinical assessment technique using multi-radiotracer positron emission tomography/magnetic resonance (PET/MR) in prostate cancer
- to establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer
- to establish the imaging biomarker using PET/MR for clinical assessment of prostate cancer and early detection of recurrent prostate cancer
Detailed description
To establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer
- Recruiting 30 patients with prostate cancer ahead to radical prostatectomy
- PET/MR using 18F-choline with dedicated prostate MRI in all patients
- PET/MR using 18fluoride(F)-fluorodeoxyglucose(FDG)in all patients after 2-7 days
- PET/CT using 18F-FDG in all patient immediate after 18F-FDG PET/MR
- outcome assessment: comparison of scan time, image quality, tumor detection rate, standardized uptake values of lesions
- establishing optimal imaging technique for prostate PET/MR
To establish the imaging biomarker using PET/MR for clinical assessment of prostate cancer
- comparison of findings on PET/MR, MRI and PET/CT with pathological mapping after radical prostatectomy
- outcome assessment: accuracy of PET/MR for localization and staging of prostate cancer compared with MRI only and PET/CT only
To establish the imaging biomarker using PET/MR for early detection of recurrent prostate cancer
- Recruiting 15 patients with recurrent prostate cancer treated by surgery, hormone, or radiation therapy
- Recruiting 15 patients with treated prostate cancer without recurrence
- PET/MR using 18F-choline with dedicated prostate MRI in all patients
- PET/MR using 18F-FDG in all patients after 2-7 days
- PET/CT using 18F-FDG in all patient immediate after 18F-FDG PET/MR
- comparison of findings on PET/MR, MRI, and PET/CT with clinical data in two patient groups with or without recurrent prostate cancer
- outcome assessment: accuracy of PET/MR for early detection and localization of recurrent prostate cancer compared with MRI only and PET/CT only
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/MR | Experimental | Device: PET/MRMulti-radiotracer PET/MR will be performed to compare the accuracy of tumor detection in patient with primary prostate cancer |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patient with prostate cancer before treatment
- patient with prostate cancer treated
- patient with prostate cancer recurrent
Key exclusion criteria (2 listed)
- patient with contraindication for MRI
- Patient with severe renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MRAlso: Biograph mMR, Siemens HealthcareMulti-radiotracer PET/MR will be performed in patients with primary and recurrent prostate cancer | Device | PET/MR |
Primary outcome
accuracy of PET/MR predicting localization and staging of prostate cancer
Time frame: 1 week after radical prostatectomy
analysis of accuracy of PET/MR predicting localization and staging of prostate cancer by comparison of PET/MR findings with pathological mapping images after radical prostatectomy
1 secondary outcome
accuracy of early detection and localization of recurrent prostate cancer
Time frame: 1 week after PET/MR imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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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.
Jeong Yeon Cho, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MR in people with Prostate Cancer Recurrent and Stage II Prostate Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 2 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 5 Dec 2013. 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 South Korea. 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 Jeong Yeon Cho, MD (82-2-2072-3074, radjycho@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of PET/MR predicting localization and staging of prostate cancer (time frame: 1 week after radical prostatectomy). 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 5 Dec 2013.