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

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03648619
• Other study ID #: 2017-00964
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: September 2021
• Source: Kantonsspital Baden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

Diagnostic Test:
• Semi whole-body MRI
Single semi-automatic, semi whole-body MRI protocol (Dot engine)

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baden, Institute of Radiology	Baden	Aargau

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Baden

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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