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

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ClinicalTrials.gov Identifier: NCT03648619
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Hausmann, Kantonsspital Baden

Study Description
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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

Condition or disease Intervention/treatment Phase
Oncology Diagnostic Test: Semi whole-body MRI Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Clinically-indicated PET/CT and additional study-related MRI as a single Intervention.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of an Innovative Automatized "Semi-Whole-Body"-MRI Protocol to Increase Patient Comfort and Cost-effectiveness of Oncologic Imaging
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020
Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. to compare lesion detectability between wb-MRI and the gold standard PET/CT [ Time Frame: 30 minutes duration of study-related MRI protocol ]

    - 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.



Secondary Outcome Measures :
  1. Secondary outcome will be the number of lesions [ Time Frame: 5 minutes assessment of a dedicated questionnaire to assess patient comfort ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648619


Contacts
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Contact: Daniel Hausmann, MD +41564863822 daniel.hausmann@ksb.ch

Locations
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Switzerland
Kantonsspital Baden, Institute of Radiology Recruiting
Baden, Aargau, Switzerland, 5404
Contact: Rahel Kubik, MD    +41 564863802    rahel.kubik@ksb.ch   
Sponsors and Collaborators
Kantonsspital Baden
More Information
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Responsible Party: Daniel Hausmann, Head of Abdominal and Oncologic Imaging, Kantonsspital Baden
ClinicalTrials.gov Identifier: NCT03648619    
Other Study ID Numbers: 2017-00964
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms