Advanced MRI Scan Before and After Radiation Therapy for the Detection of Intracranial Metastasis
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
I. Conspicuity:
Ia. To assess the conspicuity of idealized T1 and T2 imaging at detecting brain metastases at baseline.
Ib. To assess the conspicuity (CNR) of chemical exchange saturation transfer (CEST) imaging at detecting brain metastases at baseline.
Ic. To assess the conspicuity (CNR) of advances in difference equations (Adv Diff) at detecting brain metastases at baseline.
Id. To assess the conspicuity of gradient- and spin-echo (GESE) dynamic susceptibility contrast (DSC) and standard Gradient Echo (GE) DSC at detecting brain metastases at baseline.
SECONDARY OBJECTIVES:
I. Conspicuity:
Ia. To assess the conspicuity of T2 imaging at detecting brain metastases on a per-patient basis at follow-up scans and on a per-lesion basis at baseline and at follow-up time points.
Ib. To assess the conspicuity (CNR) of CEST imaging at detecting brain metastases on a per-patient basis at follow-up scans and on a per-lesion basis at baseline and at follow-up time points.
Ic. To assess the conspicuity (CNR) of Adv Diff at detecting brain metastases on a per-patient basis at follow-up scans and on a per-lesion basis at baseline and at follow-up time points.
Id. To assess the conspicuity of GESE DSC and standard Gradient Echo (GE) DSC at detecting brain metastases on a per-patient basis at follow-up scans and on a per-lesion basis at baseline and at follow-up time points.
- Treatment response. IIa. To assess the trend of idealized quantitative T1 and T2 values of brain metastases compared to normal brain parenchyma following treatment with stereotactic radiosurgery.
IIb. To assess the ability of CEST imaging to differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery.
IIc. To assess whether Adv Diff can differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery.
IId. To assess whether GESE DSC improves differentiation of radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery compared to standard GE DSC.
IIe. To assess the ability of Adv ASL to differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery.
OUTLINE:
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.
Study Design
Arms and Interventions
| 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 Names:
Procedure: Conventional Magnetic Resonance Imaging
Undergo conventional MRI
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Conspicuity [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 [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
- Treatment response [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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An adult patient with pathology-proven solid organ cancer
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MRI of the brain with contrast, positive for at least one intra-axial metastatic lesion greater than 5 mm
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Planned treatment with stereotactic radiation
Exclusion Criteria:
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Contraindication to MR imaging
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Known allergy to gadolinium-based contrast agents
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Renal failure as defined by a glomerular filtration rate (GFR) less than 30 or the use of hemodialysis
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Pregnant
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Patients less than 18 years of age will be excluded
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Jason M Johnson, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-1008
- NCI-2021-03217
- 2019-1008