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Advanced MRI Scan Before and After Radiation Therapy for the Detection of Intracranial Metastasis

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: NCT04870645
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This clinical trial studies the different types of investigational imaging techniques called sequences during magnetic resonance imaging (MRI) of the head before and after radiation therapy in patients with cancer that has spread to the brain (intracranial metastases). This clinical trial also compares these new techniques with standard MRI imaging to see if sequences provide better images. Diagnostic procedures, such as MRI, may help find and diagnose solid organ cancer and find out how far the disease has spread.

Condition or disease Intervention/treatment Phase
Malignant Solid Neoplasm Metastatic Malignant Neoplasm in the Brain Procedure: Advanced Magnetic Resonance Imaging Procedure: Conventional Magnetic Resonance Imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Advanced MRI for Intracranial Metastasis Treated With Stereotactic Radiosurgery
Actual Study Start Date : March 30, 2021
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: Diagnostic (advanced MRI)
Patients undergo conventional and advanced MRI over 60 minutes within 14 days before the start of scheduled brain radiation treatment. Patients then undergo 7 additional MRI over 60 minutes each between 4-16 weeks apart.
Procedure: Advanced Magnetic Resonance Imaging
Undergo advanced MRI
Other Name: AMRI

Procedure: Conventional Magnetic Resonance Imaging
Undergo conventional MRI
Other Name: Conventional MRI




Primary Outcome Measures :
  1. Conspicuity [ Time Frame: through study completion, an average of 1 year ]
    Will be performed on the largest lesion within each patient at baseline, and the analysis will be repeated considering all lesions.

  2. Sensitivity [ Time Frame: through study completion, an average of 1 year ]
    The sensitivity of each method at detecting lesions as determined by T1 weighting will be reported with 95% confidence intervals. Analyses will also be performed at the subsequent scans as numbers permit.


Secondary Outcome Measures :
  1. Treatment response [ Time Frame: through study completion, an average of 1 year ]
    Brain metastases "treatment response" will be defined by size and contrast to noise ratio (CNR). Size: treatment response in a lesion will be considered as a decrease in size of 30%. CNR: treatment response will be considered as a decrease in T1 post-contrast CNR of at least 20%. Metastases that do not meet these criteria for treatment response will be considered treatment failure. Will calculate the CNR in patients with lesions that respond to treatment and in patients with local failure and will compare these by using a Wilcoxon rank-sum test. If numbers permit, analyses may be repeated using all lesions. The CNR will be compared between lesions with treatment change and those that are progressive disease using a Wilcoxon rank-sum test.



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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:

  • An adult patient with pathology-proven solid organ cancer
  • MRI of the brain with contrast, positive for at least one intra-axial metastatic lesion greater than 5 mm
  • Planned treatment with stereotactic radiation

Exclusion Criteria:

  • Contraindication to MR imaging
  • Known allergy to gadolinium-based contrast agents
  • Renal failure as defined by a glomerular filtration rate (GFR) less than 30 or the use of hemodialysis
  • Pregnant
  • Patients less than 18 years of age will be excluded

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): NCT04870645


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jason M. Johnson    713-792-8443    jjohnson12@mdanderson.org   
Principal Investigator: Jason M. Johnson         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Jason M Johnson M.D. Anderson Cancer Center
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04870645    
Other Study ID Numbers: 2019-1008
NCI-2021-03217 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-1008 ( Other Identifier: M D Anderson Cancer Center )
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021

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