Automatized Semi-Whole-Body-MRI Protocol for Cancer Staging

Study Overview
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Brief Summary
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The aims of this study are to evaluate the image quality and robustness of a whole-body MRI protocol by using an innovative partially automatic algorithm (DOT engine), that automatically optimizes protocol parameters depending on body region (e.g. thorax versus abdomen) to compare lesion detectability between wb-MRI and the gold standard positron emission tomography (PET)/CT to compare patient comfort between PET/CT and wb-MRI using a dedicated questionnaire to compare duration of image acquisition with regards to cost-effectiveness

Detailed Description
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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.

Official Title
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Evaluation of an Innovative Automatized Semi-Whole-Body-MRI Protocol to Increase Patient Comfort and Cost-effectiveness of Oncologic Imaging

Conditions
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Oncology

Intervention / Treatment
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* Diagnostic Test: Semi whole-body MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically indicated PET/CT for cancer staging or response assess-ment in patients with histopathologically confirmed solid tumors (e.g.prostate, breast, gastrointestinal, testicles) MRI can be scheduled within 1 week to PET/CT exam Exclusion Criteria: general MRI contraindications (devices (e.g. certain pacemakers), pregnancy, claustrophobia) severely reduced general condition impaired renal function

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Clinically-indicated PET/CT and additional study-related MRI as a single Intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oncologic patients<br>Oncologic patients with a previous PET/CT for whole-body staging | Diagnostic Test: Semi whole-body MRI<br>* Single semi-automatic, semi whole-body MRI protocol (Dot engine)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 5 minutes assessment of a dedicated questionnaire to assess patient comfort |