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

Bone Metastasis Clinical Trial

— FNa-CHOLINE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02876991
• Other study ID #: 2015-A00021-48
• Status: Recruiting
• Phase: N/A
• First received: August 10, 2016
• Last updated: August 19, 2016
• Start date: February 2016
• Est. completion date: February 2019

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: Pierre OLIVIER, Pr
• Email: p.olivier[@]chru-nancy.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenocarcinoma
• Bone Marrow Diseases
• Bone Metastasis
• Bone Neoplasms
• Neoplasm Metastasis
• Prostatic Neoplasms
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
France	Service de Médecine Nucléaire CHRU de Nancy-Brabois	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Inter-strategy concordance of diagnosis evaluated by kappa coefficient	Concordance between results of choline PET and sodium fluoride PET	Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)	No
Secondary	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)	No
Secondary	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)	No