Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma (FNa-CHOLINE)
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|ClinicalTrials.gov Identifier: NCT02876991|
Recruitment Status : Unknown
Verified August 2016 by Central Hospital, Nancy, France.
Recruitment status was: Recruiting
First Posted : August 24, 2016
Last Update Posted : August 24, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastasis||Procedure: Sodium fluoride PET||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||February 2019|
Sodium fluoride PET
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 [ Time Frame: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks) ]Concordance between results of choline PET and sodium fluoride PET
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876991
|Contact: Pierre OLIVIER, Prfirstname.lastname@example.org|
|Service de Médecine Nucléaire CHRU de Nancy-Brabois||Recruiting|
|Contact: Pierre OLIVIER, Pr|
|Principal Investigator:||Pierre OLIVIER, Pr||Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandœuvre-lès-Nancy|