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

Advanced MRI for Intracranial Metastasis Treated With Stereotactic Radiosurgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04870645
Enrollment
15
Registered
2021-05-03
Start date
2021-03-30
Completion date
2023-08-29
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Solid Neoplasm

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.

Interventions

Undergo advanced MRI

Undergo conventional MRI

Contrast agent

Contrast agent

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Contrast to Noise RatioParticipants enrolled in the study were followed for variable amounts of times (up to 2 years and 4 months) from the date of their enrollment and baseline imagingContrast enhancement compared to baseline and normalized to background noise

Countries

United States

Participant flow

Recruitment details

Patients with brain metastases were scanned on a dual-energy CT scanner following iohexol injection at four different time points

Participants by arm

ArmCount
Advanced MRI for Intracranial Metastasis Treated With Stereotactic Radiosurgery
Single Arm
15
Total15

Baseline characteristics

CharacteristicAdvanced MRI for Intracranial Metastasis Treated With Stereotactic Radiosurgery
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
8 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
12 Participants
Region of Enrollment
United States
15 Participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 15
other
Total, other adverse events
0 / 15
serious
Total, serious adverse events
0 / 15

Outcome results

Primary

Contrast to Noise Ratio

Contrast enhancement compared to baseline and normalized to background noise

Time frame: Participants enrolled in the study were followed for variable amounts of times (up to 2 years and 4 months) from the date of their enrollment and baseline imaging

ArmMeasureValue (MEAN)Dispersion
Advanced MRI for Intracranial Metastasis Treated With Stereotactic RadiosurgeryContrast to Noise Ratio3.2 RatioStandard Deviation 1.1
p-value: <0.05Statistical Significance

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026