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An improved diagnosis of bone metastases in prostate cancer patients can have a significant impact on treatment strategy and probably survival as well.
The primary purpose of the project is to determine the diagnostic accuracy of bone SPECT-CT, choline-PET-CT, PSMA-PET-CT, NaF-PET-CT and Whole-body MRI in the diagnosis of bone metastases in prostate cancer patients.
The project is a prospective diagnostic test accuracy study. The project takes place at Herlev Hospital and is a collaboration between the Department of Radiology and the Department of Clinical Physiology and Nuclear Medicine.
The investigators want to include 300 prostate cancer patients referred to our standard diagnostic imaging (NaF-PET-CT scan) by the clinicians.
In addition to the standard diagnostic imaging (NaF-PET-CT-scan), two project will be performed on all participants. The project has three arms with the following scanning combinations:
A) Whole-body MRI + SPECT-CT B) Whole-body MRI + Cholin-PET-CT C) Whole-body MRI + PSMA-PET-CT The recruitment of project participants takes place on the day when the patients are undergoing a NaF-PET-CT scan in the course of regular clinical practice at our institution.
All readers are experienced radiologists or specialists in nuclear medicine. Patient identification on each scan will be anonymized and the reader will not have access to clinical and biochemical information or previous imaging studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPECT-CT | Other | The participants will undergo two project scans: WB-MRI and SPECT-CT |
|
| Cholin-PET-CT | Other | The participants will undergo two project scans: WB-MRI and Cholin-PET-CT |
|
| PSMA-PET-CT | Other | The participants will undergo two project scans: WB-MRI and PSMA-PET-CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WB-MRI | Diagnostic Test | scanning methods |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy | Sensitivity and specificity | The two project scans will be performed within a maximum of 30 days from the performance of the NaF-PET-CT scan |
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Inclusion Criteria:
A subject will be eligible for project participation if he meets all of the following criteria:
Exclusion Criteria:
A subject will be excluded from the protocol if he meets one or more of the following criteria:
Only males can get prostate cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Dyrberg Mortensen, MD | Contact | +45 38681002 | eva.dyrberg@regionh.dk | |
| Henrik S. Thomsen, Professor | Contact | +45 38683212 | henrik.thomsen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Henrik S. Thomsen, Professor | Department of Radiology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radioogy/Department of Nuclear Medicine | Recruiting | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| D000072098 | Single Photon Emission Computed Tomography Computed Tomography |
| ID | Term |
|---|---|
| D015899 | Tomography, Emission-Computed, Single-Photon |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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Study participants will be allocated to the "ongoing project arm" at the time of enrollment.
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| SPECT-CT | Diagnostic Test | scanning methods |
|
| Cholin-PET-CT | Diagnostic Test | scanning methods |
|
| PSMA-PET-CT | Diagnostic Test |
|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |