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

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

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

Study Overview

• Status: Terminated
• Conditions: Oncology
• Intervention / Treatment: Diagnostic test: Semi whole-body MRI

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Aargau
    • Baden, Aargau, Switzerland, 5404
      • Kantonsspital Baden, Institute of Radiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Oncologic patients; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kantonsspital Baden

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2017-00964

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No