Automatized "Semi-Whole-Body"-MRI Protocol for Cancer Staging
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|ClinicalTrials.gov Identifier: NCT03648619|
Recruitment Status : Suspended (Insufficient recruitment)
First Posted : August 27, 2018
Last Update Posted : September 2, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Oncology||Diagnostic Test: Semi whole-body MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Clinically-indicated PET/CT and additional study-related MRI as a single Intervention.|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of an Innovative Automatized "Semi-Whole-Body"-MRI Protocol to Increase Patient Comfort and Cost-effectiveness of Oncologic Imaging|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
Oncologic patients with a previous PET/CT for whole-body staging
Diagnostic Test: Semi whole-body MRI
Single semi-automatic, semi whole-body MRI protocol (Dot engine)
- to compare lesion detectability between wb-MRI and the gold standard PET/CT [ Time Frame: 30 minutes duration of study-related MRI protocol ]
- 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.
- Secondary outcome will be the number of lesions [ Time Frame: 5 minutes assessment of a dedicated questionnaire to assess patient comfort ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648619
|Kantonsspital Baden, Institute of Radiology|
|Baden, Aargau, Switzerland, 5404|