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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
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
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jason M. Johnson 713-792-8443 firstname.lastname@example.org|
|Principal Investigator: Jason M. Johnson|
|Principal Investigator:||Jason M Johnson||M.D. Anderson Cancer Center|