Clinical trial NCT03648619: Automatized "Semi-Whole-Body"-MRI Protocol for Cancer Staging
Official title: Evaluation of an Innovative Automatized "Semi-Whole-Body"-MRI Protocol to Increase Patient Comfort and Cost-effectiveness of Oncologic Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Oncology
Lead sponsor: Kantonsspital Baden
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinically-indicated PET/CT and additional study-related MRI as a single Intervention.
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: to compare lesion detectability between wb-MRI and the gold standard PET/CT
timeFrame: 30 minutes duration of study-related MRI protocol
Secondary outcomes:
measure: Secondary outcome will be the number of lesions
timeFrame: 5 minutes assessment of a dedicated questionnaire to assess patient comfort
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden, Institute of Radiology
state: Aargau
Study officials:
References: