Bone Metastasis
Conditions
Keywords
choline positron emission tomography, occult recurrence, prostatic adenocarcinoma, sodium fluoride positron emission tomography
Brief 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.
Interventions
PROCEDURESodium 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.
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prostate adenocarcinoma regardless of Gleason score * Patients having undergone radical treatment (prostatectomy or radiotherapy (external or brachytherapy) +/- conco-adjuvant hormonal therapy) * Level of Prostate Specific Antigen (PSA) indicating recurrence: PSA \> 0.2 ng/ml in case of prostatectomy (in 2 consecutive tests in less than 1 month) or elevation of PSA of at least 2 ng/ml above nadir in case of radiotherapy or brachytherapy (in 2 consecutive tests in less than 1 month) * Negative conventional assessment (thoracic-abdominal-pelvic scanner and bone scintigraphy) during 6 weeks before inclusion * Patient having undergone a choline PET at CHRU Nancy * Signed informed consent * Affiliation to French social security * Absence of contraindications to sodium fluoride PET
Exclusion criteria
* Refusal or impossibility of informed consent * Patient incapable to consent * Patient deprived of liberty * Person under legal protection * Person in life-and-death emergency * Drug addiction, alcoholism, psychological problems affecting patient compliance * Severe co-morbidities * Modification of hormonal therapy (if applicable) during 3 months before inclusion * Renal insufficiency (creatinine clearance \< 60 ml/min) detected during last assessment before inclusion * Other progressive tumors (recovered cancers are not a non-inclusion criteria)
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter-strategy concordance of diagnosis evaluated by kappa coefficient | 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 | 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) | — |
Countries
France
Contacts
Primary ContactPierre OLIVIER, Pr
Outcome results
None listed