Role of PET/CT With Fluorine-18 Tracers of Bone Metastases in Prostate Cancer (FLUPROSTIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01501630|
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : October 14, 2015
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Device: performance of PET/CT and whole-body MRI|
In patients with high risk prostate cancer and high PSA levels, PET/CT with fluoride (18F) and FLUOROCHOLINE (18F) and whole-body MRI will be performed within one month.
Data of a 6 month follow-up after those examination will be made available to a panel of independent experts. They will determine the standard of truth (SOT) concerning the invasion of the skeleton and also of soft tissue by prostate cancer tissue, the impact of each imaging modality on patient management and the adequacy of the decisions. In some cases (anti-hormone treatment without histology), it will not be possible to determine the SOT.
By comparison of the results of blind readings for each imaging modality with the standard of truth, the diagnostic performance will be determined.
By simulation, several strategies will be constructed concerning the best examinations to be performed and the sequence according to the precise clinical circumstances. Their cost and effectiveness will be evaluated.
|Study Type :||Observational|
|Actual Enrollment :||112 participants|
|Official Title:||Role of PET/CT With Fluorine-18 Tracers and of Diffusion Weighted Whole-body MRI in the Early Detection of Bone Metastases in Prostate Cancer|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
PET/CT and MRI
all patients will benefit from PET/CT and MRI
Device: performance of PET/CT and whole-body MRI
For PET/CT radiopharmaceuticals, both registered in France:Fluoride (18F)FLUOROCHOLINE (18F)No contrast agent scheduled for MRI in the study RadiopharmaceuticalsSingle use, 2-4 MBq/kg body weight, IV infusion
- bone metastases [ Time Frame: within 6 months ]Follow up data (histology, imaging, PSA levels) during 6 months to determine the standard of truth and the adequacy of the management decided on basis of imaging modalities.
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): NCT01501630
|Service Médecine Nucléaire - Hôpital TENON|
|Paris, France, 75020|
|Principal Investigator:||Jean-Noël TALBOT, MD,PhD||Assistance Publique - Hôpitaux de Paris|