Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04870645
Status:
COMPLETED
Last Update Posted:
2023-09-05
First Post:
2021-04-26
Brief Title:
Advanced MRI Scan Before and After Radiation Therapy for the Detection of Intracranial Metastasis
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Advanced MRI for Intracranial Metastasis Treated With Stereotactic Radiosurgery
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
PRIMARY OBJECTIVES
I Conspicuity
Ia To assess the conspicuity of idealized T1 and T2 imaging at detecting brain metastases at baseline Quantitative MRI Ib To assess the conspicuity CNR of chemical exchange saturation transfer CEST imaging at detecting brain metastases at baseline CEST MRI Ic To assess the conspicuity CNR of advances in difference equations Adv Diff at detecting brain metastases at baseline Multiple B Value Diffusion Imaging Adv Diff 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 GESE DSC perfusion imaging
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 Quantitative MRI 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 CEST MRI 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 Multiple B Value Diffusion Imaging Adv Diff 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 GESE DSC perfusion imaging II 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 Quantitative MRI IIb To assess the ability of CEST imaging to differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery CEST MRI IIc To assess whether Adv Diff can differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery Multiple B Value Diffusion Imaging Adv Diff 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 GESE DSC perfusion imaging IIe To assess the ability of Adv arterial spin labeling ASL to differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery Multiple inversion time TI ASL Adv ASL perfusion
OUTLINE
Patients undergo conventional and advanced MRI scans over 60 minutes within 14 days before the start of scheduled brain radiation treatment Patients then undergo 7 additional MRI scans over 60 minutes each between 4-16 weeks apart Patients may receive gadolinium andor iopamidol during MRI scans
I Conspicuity
Ia To assess the conspicuity of idealized T1 and T2 imaging at detecting brain metastases at baseline Quantitative MRI Ib To assess the conspicuity CNR of chemical exchange saturation transfer CEST imaging at detecting brain metastases at baseline CEST MRI Ic To assess the conspicuity CNR of advances in difference equations Adv Diff at detecting brain metastases at baseline Multiple B Value Diffusion Imaging Adv Diff 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 GESE DSC perfusion imaging
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 Quantitative MRI 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 CEST MRI 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 Multiple B Value Diffusion Imaging Adv Diff 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 GESE DSC perfusion imaging II 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 Quantitative MRI IIb To assess the ability of CEST imaging to differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery CEST MRI IIc To assess whether Adv Diff can differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery Multiple B Value Diffusion Imaging Adv Diff 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 GESE DSC perfusion imaging IIe To assess the ability of Adv arterial spin labeling ASL to differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery Multiple inversion time TI ASL Adv ASL perfusion
OUTLINE
Patients undergo conventional and advanced MRI scans over 60 minutes within 14 days before the start of scheduled brain radiation treatment Patients then undergo 7 additional MRI scans over 60 minutes each between 4-16 weeks apart Patients may receive gadolinium andor iopamidol during MRI scans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-03217 | REGISTRY | None | None |
| 2019-1008 | OTHER | M D Anderson Cancer Center | None |