Malignant Solid Neoplasm
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Contrast to Noise Ratio | 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 | Contrast 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
| Arm | Count |
|---|---|
| Advanced MRI for Intracranial Metastasis Treated With Stereotactic Radiosurgery Single Arm | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Advanced 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 type | EG000 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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Advanced MRI for Intracranial Metastasis Treated With Stereotactic Radiosurgery | Contrast to Noise Ratio | 3.2 Ratio | Standard Deviation 1.1 |