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Trial record 2 of 288 for:    Sodium Fluoride OR Duraphat

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)

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ClinicalTrials.gov Identifier: NCT02876991
Recruitment Status : Unknown
Verified August 2016 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : August 24, 2016
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.

Condition or disease Intervention/treatment Phase
Bone Metastasis Procedure: Sodium fluoride PET Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : February 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : February 2019

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Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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 Measures :
  1. 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

  2. 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) ]
  3. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876991


Contacts
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Contact: Pierre OLIVIER, Pr p.olivier@chru-nancy.fr

Locations
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France
Service de Médecine Nucléaire CHRU de Nancy-Brabois Recruiting
Vandœuvre-lès-Nancy, France
Contact: Pierre OLIVIER, Pr         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Pierre OLIVIER, Pr Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandœuvre-lès-Nancy

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02876991     History of Changes
Other Study ID Numbers: 2015-A00021-48
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Central Hospital, Nancy, France:
choline positron emission tomography
occult recurrence
prostatic adenocarcinoma
sodium fluoride positron emission tomography

Additional relevant MeSH terms:
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Fluorides
Sodium Fluoride
Listerine
Adenocarcinoma
Neoplasm Metastasis
Recurrence
Bone Neoplasms
Bone Marrow Diseases
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Disease Attributes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Choline
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Lipotropic Agents
Hypolipidemic Agents