NCT02876991

Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-08-01
• Completion: 2019-02-01
• First posted: 2016-08-24
• Last updated: 2016-08-24

Locations

1 site across 1 country: France