An interventional study of Sodium fluoride PET in Bone Metastasis, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-24.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic
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:
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 110 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Before inclusion, patients undergo choline PET to assess an occult recurrence of prostate cancer. After inclusion, they undergo sodium fluoride PET.
Procedure: Sodium fluoride PET
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.
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)
Inter-strategy concordance of diagnosis evaluated by kappa coefficient
Concordance between results of choline PET and sodium fluoride 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 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)
Plan to share: No
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This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France