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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 23, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
to compare lesion detectability between wb-MRI and the gold standard PET/CT [ Time Frame: 30 minutes duration of study-related MRI protocol ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
to compare patient comfort between PET/CT and wb-MRI using a dedicated questionnaire [ Time Frame: 5 minutes assessment of a dedicated questionnaire to assess patient comfort ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Automatized "Semi-Whole-Body"-MRI Protocol for Cancer Staging
Official Title  ICMJE Evaluation of an Innovative Automatized "Semi-Whole-Body"-MRI Protocol to Increase Patient Comfort and Cost-effectiveness of Oncologic Imaging
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Oncology
Intervention  ICMJE Diagnostic Test: Semi whole-body MRI
Single semi-automatic, semi whole-body MRI protocol (Dot engine)
Study Arms  ICMJE Oncologic patients
Oncologic patients with a previous PET/CT for whole-body staging
Intervention: Diagnostic Test: Semi whole-body MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniel Hausmann, MD +41564863822 daniel.hausmann@ksb.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03648619
Other Study ID Numbers  ICMJE 2017-00964
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniel Hausmann, Kantonsspital Baden
Study Sponsor  ICMJE Kantonsspital Baden
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kantonsspital Baden
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP