NCT02876991

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

2.5 years

First QC Date

August 10, 2016

Last Update Submit

August 19, 2016

Conditions

Bone Metastasis

Keywords

choline positron emission tomographyoccult recurrenceprostatic adenocarcinomasodium fluoride positron emission tomography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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)

  • 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)

Study Arms (1)

Sodium fluoride PET

OTHER

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

Interventions

Sodium fluoride PETPROCEDURE

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.

Sodium fluoride PET

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Patient having undergone a choline PET at CHRU Nancy
  • Signed informed consent
  • Affiliation to French social security
  • Absence of contraindications to sodium fluoride PET

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine Nucléaire CHRU de Nancy-Brabois

Vandœuvre-lès-Nancy, France

RECRUITING

Study Officials

  • Pierre OLIVIER, Pr

    Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandœuvre-lès-Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre OLIVIER, Pr

CONTACT

p.olivier@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 24, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2018

Study Completion

February 1, 2019

Last Updated

August 24, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)