Bone MetastasisFNa-CHOLINENCT02876991
Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma
A study testing Sodium fluoride PET in people with Bone Metastasis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose is to evaluate if sodium fluoride PET in patients having already undergone a choline PET negative for bone extension (non-metastatic status) modifies the status of patients concerning the existence or not of bone metastases. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bone Metastasis
- What is being tested?
- Sodium fluoride PET
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Feb 2019
- 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
- Prostate adenocarcinoma regardless of Gleason score
- Patients having undergone radical treatment (prostatectomy or radiotherapy (external or brachytherapy) +/- conco-adjuvant hormonal therapy)
- Level of Prostate Specific Antigen (PSA) indicating recurrence: PSA > 0.2 ng/ml in case of prostatectomy (in 2 consecutive tests in less than 1 month) or elevation of PSA of at least 2 ng/ml above nadir in case of radiotherapy or brachytherapy (in 2 consecutive tests in less than 1 month)
- Negative conventional assessment (thoracic-abdominal-pelvic scanner and bone scintigraphy) during 6 weeks before inclusion
- Patient having undergone a choline PET at CHRU Nancy
- Signed informed consent
- Affiliation to French social security
- Absence of contraindications to sodium fluoride PET
Who cannot join
- Refusal or impossibility of informed consent
- Patient incapable to consent
- Patient deprived of liberty
- Person under legal protection
- Person in life-and-death emergency
- Drug addiction, alcoholism, psychological problems affecting patient compliance
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- Severe co-morbidities
- Modification of hormonal therapy (if applicable) during 3 months before inclusion
- Renal insufficiency (creatinine clearance < 60 ml/min) detected during last assessment before inclusion
- Other progressive tumors (recovered cancers are not a non-inclusion criteria)
Trial locations and contacts
1 site in 1 country.
Pierre OLIVIER, Pr contact
France1 site, 1 recruiting
- Recruiting
Service de Médecine Nucléaire CHRU de Nancy-Brabois
Vandœuvre-lès-Nancy
Pierre OLIVIER, Pr
About this study
The purpose is to evaluate if sodium fluoride PET in patients having already undergone a choline PET negative for bone extension (non-metastatic status) modifies the status of patients concerning the existence or not of bone metastases.
Secondary purposes are:
- To evaluate if detection of bone metastasis by sodium fluoride PET, not detected by choline PET, leads to change of treatment
- To evaluate inter-technique concordance (choline vs sodium fluoride PET) of results (metastatic status and number of lesions)
- To evaluate the inter-judge concordance of interpretation of sodium fluoride PET
- To study the discordance of metastatic status of 2 techniques.
- Conditions
- Bone Metastasis
- Being tested
- Sodium fluoride PET
- Keywords
- choline positron emission tomography, occult recurrence, prostatic adenocarcinoma, sodium fluoride positron emission tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium fluoride PETProcedure or surgery
Sodium fluoride Pet is realized maximum after 4 weeks from choline PET (inclusion).
Injection of 4MBq 18F-FNa/kg of body weight is followed after 60 min (± 5 min) by acquisition of images on Biograph 6 PET/CT scanner (SIEMENS).
Data from sodium fluoride PET are interpreted independently and blind from other data by 3 medical doctors (2 at hospital of Nancy and 1 at hospital of Strasbourg) (for inter-judge reproducibility); a second interpretation of data is consensually realized by 2 of 3 readers, limited to discordant analyses (metastatic status or not, and/or number of lesions); results from this second interpretation are final results.
| Study group | Role | What they receive |
|---|---|---|
| Sodium fluoride PET | Other | Before inclusion, patients undergo choline PET to assess an occult recurrence of prostate cancer.
After inclusion, they undergo sodium fluoride PET. Receives: Procedure: Sodium fluoride PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with choline PET negative and sodium fluoride PET positive for bone extension (metastasis)
Measured: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
Secondary outcomes (3)
Inter-strategy concordance of diagnosis evaluated by kappa coefficient
Concordance between results of choline PET and sodium fluoride PET
Measured: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
Metastatic status and number of lesions detected respectively by sodium fluoride PET and choline PET
Measured: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
Metastatic status and number of lesions identified by 3 medical doctors of 2 different centres in sodium fluoride PET
Measured: Execution of sodium fluoride PET (from baseline up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre OLIVIER, Pr, Principal investigator, Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandœuvre-lès-Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876991
- Sponsor's protocol ID
- 2015-A00021-48
- Acronym
- FNa-CHOLINE
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02876991
- Acronym / sponsor ID
- FNa-CHOLINE / 2015-A00021-48
- Conditions
- Bone Metastasis
- Keywords
- choline positron emission tomography, occult recurrence, prostatic adenocarcinoma, sodium fluoride positron emission tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 24 Aug 2016 (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.
The purpose is to evaluate if sodium fluoride PET in patients having already undergone a choline PET negative for bone extension (non-metastatic status) modifies the status of patients concerning the existence or not of bone metastases.
Secondary purposes are:
- To evaluate if detection of bone metastasis by sodium fluoride PET, not detected by choline PET, leads to change of treatment
- To evaluate inter-technique concordance (choline vs sodium fluoride PET) of results (metastatic status and number of lesions)
- To evaluate the inter-judge concordance of interpretation of sodium fluoride PET
- To study the discordance of metastatic status of 2 techniques.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium fluoride PET | Other | Procedure: Sodium fluoride PETBefore inclusion, patients undergo choline PET to assess an occult recurrence of prostate cancer. After inclusion, they undergo sodium fluoride PET. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Prostate adenocarcinoma regardless of Gleason score
- Patients having undergone radical treatment (prostatectomy or radiotherapy (external or brachytherapy) +/- conco-adjuvant hormonal therapy)
- Level of Prostate Specific Antigen (PSA) indicating recurrence: PSA > 0.2 ng/ml in case of prostatectomy (in 2 consecutive tests in less than 1 month) or elevation of PSA of at least 2 ng/ml above nadir in case of radiotherapy or brachytherapy (in 2 consecutive tests in less than 1 month)
- Negative conventional assessment (thoracic-abdominal-pelvic scanner and bone scintigraphy) during 6 weeks before inclusion
- Patient having undergone a choline PET at CHRU Nancy
Key exclusion criteria (10 listed)
- Refusal or impossibility of informed consent
- Patient incapable to consent
- Patient deprived of liberty
- Person under legal protection
- Person in life-and-death emergency
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 |
|---|---|---|
| Sodium fluoride PETSodium fluoride Pet is realized maximum after 4 weeks from choline PET (inclusion). Injection of 4MBq 18F-FNa/kg of body weight is followed after 60 min (± 5 min) by acquisition of images on Biograph 6 PET/CT scanner (SIEMENS). Data from sodium fluoride PET are interpreted independently and blind from other data by 3 medical doctors (2 at hospital of Nancy and 1 at hospital of Strasbourg) (for inter-judge reproducibility); a second interpretation of data is consensually realized by 2 of 3 readers, limited to discordant analyses (metastatic status or not, and/or number of lesions); results from this second interpretation are final results. | Procedure or surgery | Sodium fluoride PET |
Primary outcome
Percentage of patients with choline PET negative and sodium fluoride PET positive for bone extension (metastasis)
Time frame: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
3 secondary outcomes
Inter-strategy concordance of diagnosis evaluated by kappa coefficient
Time frame: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
Metastatic status and number of lesions detected respectively by sodium fluoride PET and choline PET
Time frame: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
Metastatic status and number of lesions identified by 3 medical doctors of 2 different centres in sodium fluoride PET
Time frame: Execution of sodium fluoride PET (from baseline up to 4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- 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.
Pierre OLIVIER, Pr contact
Pierre OLIVIER, Pr principal investigator
Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandœuvre-lès-Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium fluoride PET in people with Bone Metastasis, run by Central Hospital, Nancy, France at 1 site in France.
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 8 inclusion and 10 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 24 Aug 2016. 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 France. 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 Pierre OLIVIER, Pr (p.olivier@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with choline PET negative and sodium fluoride PET positive for bone extension (metastasis) (time frame: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 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 24 Aug 2016.