18F-NaF-PET/MR vs 99mTc-MDP-SPECT/CT to Detect Bone Metastases in Prostate Cancer Patients.

Study Overview
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Brief Summary
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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.

Official Title
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18F-NaF-PET/MR vs 99mTc-MDP-SPECT/CT to Detect Bone Metastases in Prostate Cancer Patients.

Conditions
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Bone Metastases, Prostate Cancer

Intervention / Treatment
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* Other: scintigraphy 99mTc-MDP-SPECT/CT.
* Other: 18F-NaF-PET/MR


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prostate cancer patient, with up to five metastases<br>prostate cancer patient, with up to five metastases (oligo-bone metastatic) based on scintigraphy 99mTc-MDP-SPECT/CT. | Other: scintigraphy 99mTc-MDP-SPECT/CT.<br>* SPECT/CT will be performed for every patient in the frame of their clinical follow up<br>Other: 18F-NaF-PET/MR<br>* 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<br>|

What is the study measuring?
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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) | 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. | through study completion, an average of 2 years | 

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. | Sensitivity and specificity of PET and SPECT for the detection of secondary bone lesions (gold standard: clinical and imaging follow up) | through study completion, an average of 2 years | 
| To determine the number of equivocal and diagnostic tests resulting from the two imaging modalities. | rate of equivocal/non equivocal findings for the two modalities | through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, bone metastases, PET/MRI