Prostate CancerNCT03105869
Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium
A study testing fluorocholine PET/CT in people with Prostate Cancer, run by Poitiers University Hospital.
Trial summary
Monocentric study. Objective : Determination of the repeatability of fluorocholine PET/CT in prostate cancer Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- fluorocholine PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2014to 31 Dec 2016
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biological suspicion of relapse of prostate cancer or initial staging of prostate cancer
- positive PET/CT with fluororocholine
Who cannot join
- -none
About this study
Monocentric study. Objective : Determination of the repeatability of fluorocholine PET/CT in prostate cancer
Read the detailed description
A second PET/CT with fluorocholine is performed within 2 weeks after a first examination performed in patient referred for an initial prostate cancer or a biological suspicion of relapse.
- Conditions
- Prostate Cancer
- Being tested
- fluorocholine PET/CT
- Keywords
- repeatability, positron emission tomography (PET), fluorocholine
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorocholine PET/CTDiagnostic test
standard diagnostic PET/CT procedure
| Study group | Role | What they receive |
|---|---|---|
| fluorocholine PET/CT | Experimental | all patients will undergo a second PET/CT with fluorocholine Receives: Diagnostic Test: fluorocholine PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
reproducibility of the results
Comparison of the number and location of identified lesions and comparison of lesion uptake
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start16 Dec 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Poitiers 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
- Model description
- test and retest in a single group of patient
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine CHEZE LE REST, Principal investigator, CHU Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105869
- Sponsor's protocol ID
- RECHOL
- Status last verified
- Jun 2017
- First submitted
- 4 Apr 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium
- ClinicalTrials.gov ID
- NCT03105869
- Acronym / sponsor ID
- RECHOL
- Conditions
- Prostate Cancer
- Keywords
- repeatability, positron emission tomography (PET), fluorocholine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 16 Dec 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 10 Apr 2017 (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.
Monocentric study. Objective : Determination of the repeatability of fluorocholine PET/CT in prostate cancer
Detailed description
A second PET/CT with fluorocholine is performed within 2 weeks after a first examination performed in patient referred for an initial prostate cancer or a biological suspicion of relapse.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- test and retest in a single group of patient
| Arm | Type | Receives |
|---|---|---|
| fluorocholine PET/CT | Experimental | Diagnostic Test: fluorocholine PET/CTall patients will undergo a second PET/CT with fluorocholine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- biological suspicion of relapse of prostate cancer or initial staging of prostate cancer
- positive PET/CT with fluororocholine
Key exclusion criteria (1 listed)
- -none
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 |
|---|---|---|
| fluorocholine PET/CTstandard diagnostic PET/CT procedure | Diagnostic test | fluorocholine PET/CT |
Primary outcome
reproducibility of the results
Time frame: 2 weeks
Comparison of the number and location of identified lesions and comparison of lesion uptake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Catherine CHEZE LE REST principal investigator
CHU Poitiers
Questions about this trial
What is this clinical trial studying?
A study testing fluorocholine PET/CT in people with Prostate Cancer, run by Poitiers University Hospital.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reproducibility of the results (time frame: 2 weeks). 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 26 Jun 2017.