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)
Primary Purpose
Bone Metastasis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sodium fluoride PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Bone Metastasis focused on measuring choline positron emission tomography, occult recurrence, prostatic adenocarcinoma, sodium fluoride positron emission tomography
Eligibility Criteria
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)
Sites / Locations
- Service de Médecine Nucléaire CHRU de Nancy-BraboisRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sodium fluoride PET
Arm Description
Before inclusion, patients undergo choline PET to assess an occult recurrence of prostate cancer. After inclusion, they undergo sodium fluoride PET.
Outcomes
Primary Outcome Measures
Percentage of patients with choline PET negative and sodium fluoride PET positive for bone extension (metastasis)
Secondary Outcome Measures
Inter-strategy concordance of diagnosis evaluated by kappa coefficient
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
Metastatic status and number of lesions identified by 3 medical doctors of 2 different centres in sodium fluoride PET
Full Information
NCT ID
NCT02876991
First Posted
August 10, 2016
Last Updated
August 19, 2016
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02876991
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastasis
Keywords
choline positron emission tomography, occult recurrence, prostatic adenocarcinoma, sodium fluoride positron emission tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sodium fluoride PET
Arm Type
Other
Arm Description
Before inclusion, patients undergo choline PET to assess an occult recurrence of prostate cancer.
After inclusion, they undergo sodium fluoride PET.
Intervention Type
Procedure
Intervention Name(s)
Sodium fluoride PET
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Inter-strategy concordance of diagnosis evaluated by kappa coefficient
Description
Concordance between results of choline PET and sodium fluoride PET
Time Frame
Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
Title
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)
Title
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)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre OLIVIER, Pr
Email
p.olivier@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre OLIVIER, Pr
Organizational Affiliation
Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandœuvre-lès-Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Médecine Nucléaire CHRU de Nancy-Brabois
City
Vandœuvre-lès-Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre OLIVIER, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma
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