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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
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
August 10, 2016
Last Updated
August 19, 2016
Sponsor
Central Hospital, Nancy, France
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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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