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

Primary Purpose

Malignant Solid Neoplasm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Advanced Magnetic Resonance Imaging
Conventional Magnetic Resonance Imaging
Gadolinium-Chelate
Iopamidol
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Solid Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (advanced MRI)

Arm Description

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.

Outcomes

Primary Outcome Measures

Conspicuity
Will be performed on the largest lesion within each patient at baseline, and the analysis will be repeated considering all lesions.
Sensitivity
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
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.

Full Information

First Posted
April 26, 2021
Last Updated
August 31, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04870645
Brief Title
Advanced MRI Scan Before and After Radiation Therapy for the Detection of Intracranial Metastasis
Official Title
Advanced MRI for Intracranial Metastasis Treated With Stereotactic Radiosurgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
August 29, 2023 (Actual)
Study Completion Date
August 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Solid Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (advanced MRI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Advanced Magnetic Resonance Imaging
Other Intervention Name(s)
AMRI
Intervention Description
Undergo advanced MRI
Intervention Type
Procedure
Intervention Name(s)
Conventional Magnetic Resonance Imaging
Other Intervention Name(s)
Conventional MRI
Intervention Description
Undergo conventional MRI
Intervention Type
Drug
Intervention Name(s)
Gadolinium-Chelate
Other Intervention Name(s)
Gadolinium Coordination Complex, Gadolinium-based Contrast Agent, Gadolinium-Chelant Complex
Intervention Description
Contrast agent
Intervention Type
Drug
Intervention Name(s)
Iopamidol
Other Intervention Name(s)
Isovue, Niopam, Solutrast
Intervention Description
Contrast agent
Primary Outcome Measure Information:
Title
Conspicuity
Description
Will be performed on the largest lesion within each patient at baseline, and the analysis will be repeated considering all lesions.
Time Frame
Through study completion, an average of 1 year
Title
Sensitivity
Description
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.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Treatment response
Description
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.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Johnson
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

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