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The aims of this study are
Whole-body imaging becomes increasingly important in oncologic patients not only for primary cancer staging, but also for assessment of response to therapy. So far, PET/CT is a key method to assess cancer-related changes of metabolism in tumors, which is crucial for response evaluation and to differentiate between benign and malignant lesions. Limitations of PET/CT include the assessment of sclerotic bone metastasis, which often do not show increased tracer uptake. Certain organ metastasis (especially in brain and liver) are also barely detectable due to physiologically increased uptake. Moreover, both CT and administration of radioactive tracer are associated with radiation exposure for patients. Whole-body MRI (wb-MRI) including functional techniques (e.g. Diffusion-weighted Imaging (DWI) to evaluate cell density) enables a functional staging and therapy assessment without use of ionizing radiation. Advantages to assess sclerotic bone lesions and organ metastases have been confirmed in recent literature. Limitations of MRI include detection of lesions in organs with high susceptibility and motion like the thorax.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oncologic patients | Other | Oncologic patients with a previous PET/CT for whole-body staging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi whole-body MRI | Diagnostic Test | Single semi-automatic, semi whole-body MRI protocol (Dot engine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| to compare lesion detectability between wb-MRI and the gold standard PET/CT | - Primary outcome will be the organ based malignant lesion detectability (Thorax, Abdomen). This will be quantified as a dichotomous variable (present/absent) for MRI and PET/CT. Outcome will be based on two board certified radiologists. In case of disagreement, consensus will be taken. Results will be obtained in a single reading after inclusion of 50 patients. Readers will be blinded to clinical patient data and results of PET/CT. | 30 minutes duration of study-related MRI protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome will be the number of lesions | Secondary outcome will be the number of lesions (Hereby, more than 5 lesions per organ will be regarded as diffuse organ involvement (e.g. diffuse bone metastasis)). Moreover, subjective image perception (e.g. image quality (1-5), quality of lesion demarcation (1-3), diagnostic confidence (1-3) will be assessed. A dedicated questionnaire to assess patient comfort and compare patient acceptance of MRI and PET/CT will be evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Baden, Institute of Radiology | Baden | Canton of Aargau | 5404 | Switzerland |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Clinically-indicated PET/CT and additional study-related MRI as a single Intervention.
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| 5 minutes assessment of a dedicated questionnaire to assess patient comfort |