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

NCT03648619 | Terminated DMC

• 1 other identifier: 2017-00964
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Oncology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcome will be the number of lesions

  5 minutes assessment of a dedicated questionnaire to assess patient comfort

Study Arms (1)

Oncologic patients

OTHER

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

Diagnostic Test: Semi whole-body MRI

Interventions

Semi whole-body MRI DIAGNOSTIC_TEST

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

Oncologic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• general MRI contraindications (devices (e.g. certain pacemakers), pregnancy, claustrophobia)
• severely reduced general condition
• impaired renal function

Sponsors & Collaborators

• Kantonsspital Baden: lead

Study Sites (1)

Kantonsspital Baden, Institute of Radiology

Baden, Canton of Aargau, 5404, Switzerland

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Abdominal and Oncologic Imaging

Model Details: Clinically-indicated PET/CT and additional study-related MRI as a single Intervention.

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)