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

NCT ID: NCT04870645

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2023-08-29

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 and/or iopamidol during MRI scans.

Conditions

Malignant Solid Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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. Patients may receive gadolinium and/or iopamidol during MRI scans.

Group Type: EXPERIMENTAL

Advanced Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo advanced MRI

Conventional Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo conventional MRI

Gadolinium-Chelate

Intervention Type: DRUG

Contrast agent

Iopamidol

Intervention Type: DRUG

Contrast agent

Interventions

Advanced Magnetic Resonance Imaging

Undergo advanced MRI

Intervention Type: PROCEDURE

Conventional Magnetic Resonance Imaging

Undergo conventional MRI

Intervention Type: PROCEDURE

Gadolinium-Chelate

Contrast agent

Intervention Type: DRUG

Iopamidol

Contrast agent

Intervention Type: DRUG

Other Intervention Names

AMRI; Conventional MRI; Gadolinium Coordination Complex; Gadolinium-based Contrast Agent; Gadolinium-Chelant Complex; Isovue; Niopam; Solutrast

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason M Johnson

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2021-03217

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-1008

Identifier Type: OTHER

Identifier Source: secondary_id

2019-1008

Identifier Type: -

Identifier Source: org_study_id