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)

August 19, 2016 updated by: Central Hospital, Nancy, France

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France
        • Recruiting
        • Service de Médecine Nucléaire CHRU de Nancy-Brabois
        • Contact:
          • Pierre OLIVIER, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sodium fluoride PET

Before inclusion, patients undergo choline PET to assess an occult recurrence of prostate cancer.

After inclusion, they undergo sodium fluoride PET.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-strategy concordance of diagnosis evaluated by kappa coefficient
Time Frame: 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
Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
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)
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
Time Frame: Execution of sodium fluoride PET (from baseline up to 4 weeks)
Execution of sodium fluoride PET (from baseline up to 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Pierre OLIVIER, Pr, Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandœuvre-lès-Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 19, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00021-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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