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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium fluoride PET | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with choline PET negative and sodium fluoride PET positive for bone extension (metastasis) | Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-strategy concordance of diagnosis evaluated by kappa coefficient | Concordance between results of choline PET and sodium fluoride PET | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre OLIVIER, Pr | Contact | p.olivier@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre OLIVIER, Pr | Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandœuvre-lès-Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Médecine Nucléaire CHRU de Nancy-Brabois | Recruiting | Vandœuvre-lès-Nancy | France |
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| 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 | Execution of sodium fluoride PET (from baseline up to 4 weeks) |