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

NCT ID: NCT03648619

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-09-01

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.

Conditions

Oncology

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Oncologic patients

Oncologic patients with a previous PET/CT for whole-body staging

Group Type: OTHER

Semi whole-body MRI

Intervention Type: DIAGNOSTIC_TEST

Single semi-automatic, semi whole-body MRI protocol (Dot engine)

Interventions

Semi whole-body MRI

Single semi-automatic, semi whole-body MRI protocol (Dot engine)

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kantonsspital Baden

OTHER

Sponsor Role: lead

Responsible Party

Daniel Hausmann

Head of Abdominal and Oncologic Imaging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kantonsspital Baden, Institute of Radiology

Baden, Canton of Aargau, Switzerland

Countries

Switzerland

Other Identifiers

2017-00964

Identifier Type: -

Identifier Source: org_study_id