Role of PET/CT With Fluorine-18 Tracers of Bone Metastases in Prostate Cancer
NCT ID: NCT01501630
Last Updated: 2015-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
112 participants
OBSERVATIONAL
2011-12-31
2014-12-31
Brief Summary
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Detailed Description
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Data of a 6 month follow-up after those examination will be made available to a panel of independent experts. They will determine the standard of truth (SOT) concerning the invasion of the skeleton and also of soft tissue by prostate cancer tissue, the impact of each imaging modality on patient management and the adequacy of the decisions. In some cases (anti-hormone treatment without histology), it will not be possible to determine the SOT.
By comparison of the results of blind readings for each imaging modality with the standard of truth, the diagnostic performance will be determined.
By simulation, several strategies will be constructed concerning the best examinations to be performed and the sequence according to the precise clinical circumstances. Their cost and effectiveness will be evaluated.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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PET/CT and MRI
all patients will benefit from PET/CT and MRI
performance of PET/CT and whole-body MRI
For PET/CT radiopharmaceuticals, both registered in France:Fluoride (18F)FLUOROCHOLINE (18F)No contrast agent scheduled for MRI in the study RadiopharmaceuticalsSingle use, 2-4 MBq/kg body weight, IV infusion
Interventions
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performance of PET/CT and whole-body MRI
For PET/CT radiopharmaceuticals, both registered in France:Fluoride (18F)FLUOROCHOLINE (18F)No contrast agent scheduled for MRI in the study RadiopharmaceuticalsSingle use, 2-4 MBq/kg body weight, IV infusion
Eligibility Criteria
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Inclusion Criteria
* Histologically proven prostate cancer.
* Abnormal plasmatic level of prostate specific antigen dating less than 3 months, initial Gleason score available
* Written informed consent.
Exclusion Criteria
* Chemotherapy or change in hormone therapy since the last PSA assay
* Contraindication to MRI without contrast agent (claustrophobia, pace maker, metallic foreign body, some cardiac valves). Metallic joint prostheses are NOT a contraindication.
* Allergic reaction to radiopharmaceuticals that will be used.
* Patient who seems not capable of staying in the gantry of the machines during the examinations without moving.
18 Years
MALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean-Noël TALBOT, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Service Médecine Nucléaire - Hôpital TENON
Paris, , France
Countries
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References
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Gauthe M, Zarca K, Aveline C, Lecouvet F, Balogova S, Cussenot O, Talbot JN, Durand-Zaleski I. Comparison of 18F-sodium fluoride PET/CT, 18F-fluorocholine PET/CT and diffusion-weighted MRI for the detection of bone metastases in recurrent prostate cancer: a cost-effectiveness analysis in France. BMC Med Imaging. 2020 Mar 2;20(1):25. doi: 10.1186/s12880-020-00425-y.
Other Identifiers
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2011-A01041-40
Identifier Type: OTHER
Identifier Source: secondary_id
P090105
Identifier Type: -
Identifier Source: org_study_id
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