- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02969564
18F-NaF-PET/MR vs 99mTc-MDP-SPECT/CT to Detect Bone Metastases in Prostate Cancer Patients.
The number of metastases in a patient with primary or recurrent prostate cancer has major prognostic implication.
The purpose is to compare, in a pilot study, the diagnostic performance of 18F-NaF-PET/MR with respect to the results of the scintigraphy 99mTc-MDP-SPECT/CT (routine exam) for determining the presence or absence of bone lesions in prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT. The gold standard will be a combination of clinical follow-up, additional imaging and biopsy, as indicated by the multidisciplinary discussion at the tumor board. The findings from whole-body 99mTc-MDP-SPECT/CT, 18F-NaF-PET/MR, and the combination of the 2 modalities will be categorized by 2 teams of 2 readers as benign or probably benign, equivocal, or malignant or probably malignant and compared with the results of follow-up for JAFROC and ROC analysis.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Geneva, Switzerland, 1205
- Geneva University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Oligo- metastatic patient with prostate cancer and bone lesions (up to five metastases) based on scintigraphy and whole-body SPECT/CT (staging or recurrence).
- Patient must be able to provide informed consent.
- Patient is ≥ 18 years old
Exclusion Criteria:
- Patient with another active malignancy.
- Patient is < 18 years old
- Patients with contraindications of MRI procedure (metal implants, cardiac pacemakers, old type of prosthesis)
- Patients with severe renal impairment (MDRD < 30)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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prostate cancer patient, with up to five metastases
prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT.
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SPECT/CT will be performed for every patient in the frame of their clinical follow up
a 18F-NaF-PET/MR will be performed, in the frame of this clinical study, to the patients to assess the difference of sensitivity of the 2 exams
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the diagnostic performance of 18F-NaF-PET/MR scanning to that of whole body 99mTc-MDP-SPECT/CT for detecting cancer that has spread to the bone (bone metastasis)
Time Frame: through study completion, an average of 2 years
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the primary measure will be differences in the area under the curves (AUC) of the receiver operating characteristic (ROC) curves that will be generated from the interpretations of each technology.
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through study completion, an average of 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess differences in sensitivity and specificity in detecting bone metastases between the two imaging modalities.
Time Frame: through study completion, an average of 2 years
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Sensitivity and specificity of PET and SPECT for the detection of secondary bone lesions (gold standard: clinical and imaging follow up)
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through study completion, an average of 2 years
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To determine the number of equivocal and diagnostic tests resulting from the two imaging modalities.
Time Frame: through study completion, an average of 2 years
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rate of equivocal/non equivocal findings for the two modalities
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through study completion, an average of 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Hematologic Diseases
- Genital Neoplasms, Male
- Prostatic Diseases
- Musculoskeletal Diseases
- Neoplastic Processes
- Bone Diseases
- Prostatic Neoplasms
- Neoplasm Metastasis
- Bone Neoplasms
- Bone Marrow Diseases
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Technetium Tc 99m Medronate
Other Study ID Numbers
- 15-118
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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