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| Name | Class |
|---|---|
| University Hospital, Geneva | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| scintigraphy 99mTc-MDP-SPECT/CT. | Other | SPECT/CT will be performed for every patient in the frame of their clinical follow up |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Oligo- metastatic patient with prostate cancer and bone lesions (up to five metastases)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospital | Geneva | 1205 | Switzerland |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 18F-NaF-PET/MR | Other | 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 |
|
rate of equivocal/non equivocal findings for the two modalities |
| through study completion, an average of 2 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |