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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00043426 | Other Identifier | University of Michigan |
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This study aims to assess changes in vascular permeability in the brain tumor, and in the surrounding brain, due to radiation therapy, using Magnetic Resonance Imaging (MRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Radiosurgery (SRS) | Patients with brain metastases receiving single fraction Stereotactic Radiosurgery (SRS). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to SRS, and 1-2 weeks and 1 month after SRS. The MRI scan will include a routine clinical MRI series. |
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| Whole Brain Radiation Therapy | Patients with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to RT, at the end of RT and 1 month after RT. The MRI scan will include a routine clinical MRI series. |
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| Stereotactic Radiation Therapy | Patients with brain metastases receiving fractionated (spread out over time) Stereotactic Radiation Therapy (FSRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to FSRT, during the last week of RT but before the last fraction and 1 month after RT. The MRI scan will include a routine clinical MRI series. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Fraction Stereotactic Radiosurgery (SRS) | Radiation | Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of the Gross Tumor Volume With a BTB Opening of Ktrans > 0.005 Min-1 | Fifty metastatic lesions from 21 patients received WBRT and 14 lesions from 9 patients treated by SRS were analyzed. Permeability of BTB (Blood-Tumor-Barrier) was quantified by the transfer constant, Ktrans, derived from dynamic contrast enhanced (DCE)-MRI that were acquired pre, 1-2 weeks after starting, and 1-month post-radiotherapy. A percentage volume of the BM with Ktrans >0.005 min-1 (%Vall) was used to evaluate the extent of BTB opening pre-RT and subsequent changes after receiving radiotherapy. The 50 lesions, from the 21 patients treated with Whole Brain Radiation Therapy, were divided into two subgroups: low-leaky (%Vall <50%) and high-leaky, based upon pre-RT measurements. Of the 50 lesions, 7 were classified as low leaky and 43 were classified as high leaky. All 14 SRS lesions were classified as high leaky. | Pre-Treatment, 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment |
| Change in Magnitude and Regional Variability of Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB) Permeability (Per Minute) in Tumor, Tumor Margin, Normal Brain and Brain Metastases | An in-house program, based on a general kinetic model, along with an MRI contrast agent, Gadopentetic Acid (Gd-DTPA), will be used to estimate vascular permeability (per minute). | Week -2 to -1, End of Treatment (WBRT), 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean K^Trans During and After Radiation Therapy | Effect of radiation dose on vascular permeability (per minute) of the Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB). Permeability of BTB was quantified by Ktrans. | Pre-treatment and 1 Month Post Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with brain metastasis receiving radiotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Yue Cao, Ph.D. | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
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Only participants enrolled onto SRS and Whole Brain Radiation Therapy arms were evaluated for the study outcomes.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Radiosurgery (SRS) | Patients with brain metastases receiving single fraction Stereotactic Radiosurgery (SRS). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to SRS, and 1-2 weeks and 1 month after SRS. The MRI scan will include a routine clinical MRI series. Single Fraction Stereotactic Radiosurgery (SRS): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment. Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fractionated Whole Brain Radiation Therapy (WBRT) | Radiation | Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment. |
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| Fractionated Stereotactic Radiation Therapy (FSRT) | Radiation | Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment. |
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| Magnetic Resonance Imaging (MRI) Assessments | Device | MRI scans will include a routine clinical MRI series. |
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| FG001 | Whole Brain Radiation Therapy | Patients with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to RT, at the end of RT and 1 month after RT. The MRI scan will include a routine clinical MRI series. Fractionated Whole Brain Radiation Therapy (WBRT): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment. Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series. |
| FG002 | Stereotactic Radiation Therapy | Patients with brain metastases receiving fractionated (spread out over time) Stereotactic Radiation Therapy (FSRT). This intervention has not been assigned by the investigator. Treatment is decided prior to enrollment. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Radiosurgery (SRS) | Patients with brain metastases receiving single fraction Stereotactic Radiosurgery (SRS). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to SRS, and 1-2 weeks and 1 month after SRS. The MRI scan will include a routine clinical MRI series. Single Fraction Stereotactic Radiosurgery (SRS): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment. Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series. |
| BG001 | Whole Brain Radiation Therapy | Patients with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to RT, at the end of RT and 1 month after RT. The MRI scan will include a routine clinical MRI series. Fractionated Whole Brain Radiation Therapy (WBRT): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment. Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Percentage of the Gross Tumor Volume With a BTB Opening of Ktrans > 0.005 Min-1 | Fifty metastatic lesions from 21 patients received WBRT and 14 lesions from 9 patients treated by SRS were analyzed. Permeability of BTB (Blood-Tumor-Barrier) was quantified by the transfer constant, Ktrans, derived from dynamic contrast enhanced (DCE)-MRI that were acquired pre, 1-2 weeks after starting, and 1-month post-radiotherapy. A percentage volume of the BM with Ktrans >0.005 min-1 (%Vall) was used to evaluate the extent of BTB opening pre-RT and subsequent changes after receiving radiotherapy. The 50 lesions, from the 21 patients treated with Whole Brain Radiation Therapy, were divided into two subgroups: low-leaky (%Vall <50%) and high-leaky, based upon pre-RT measurements. Of the 50 lesions, 7 were classified as low leaky and 43 were classified as high leaky. All 14 SRS lesions were classified as high leaky. | Fifty metastatic lesions from 21 patients received WBRT and 14 lesions from 9 patients treated by SRS were analyzed. All lesions were classified as high or low leaky dependent upon pre-RT permeability values. | Posted | Mean | Standard Error | percentage of gross tumor volume | Pre-Treatment, 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment | lesions | lesions |
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| Primary | Change in Magnitude and Regional Variability of Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB) Permeability (Per Minute) in Tumor, Tumor Margin, Normal Brain and Brain Metastases | An in-house program, based on a general kinetic model, along with an MRI contrast agent, Gadopentetic Acid (Gd-DTPA), will be used to estimate vascular permeability (per minute). | Not Posted | Week -2 to -1, End of Treatment (WBRT), 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment | Participants | ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Mean K^Trans During and After Radiation Therapy | Effect of radiation dose on vascular permeability (per minute) of the Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB). Permeability of BTB was quantified by Ktrans. | Not Posted | Pre-treatment and 1 Month Post Treatment | Participants |
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Only adverse events recorded in the medical chart as related to the study MRI scan or neurocognitive testing) were collected per protocol. No Non-Serious or Serious Adverse Events were reported to the study team.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stereotactic Radiosurgery (SRS) | Patients with brain metastases receiving single fraction Stereotactic Radiosurgery (SRS). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to SRS, and 1-2 weeks and 1 month after SRS. The MRI scan will include a routine clinical MRI series. Single Fraction Stereotactic Radiosurgery (SRS): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment. Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series. | 0 | 9 | 0 | 9 | ||
| EG001 | Whole Brain Radiation Therapy | Patients with brain metastases receiving fractionated (spread out over time) Whole Brain Radiation Therapy (WBRT). This intervention is not assigned by the investigator. Treatment has been decided prior to study enrollment. MRI scans will be performed approximately 1-2 weeks prior to RT, at the end of RT and 1 month after RT. The MRI scan will include a routine clinical MRI series. Fractionated Whole Brain Radiation Therapy (WBRT): Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment. Magnetic Resonance Imaging (MRI) Assessments: MRI scans will include a routine clinical MRI series. | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yue Cao | University of Michigan Comprehensive Cancer Center | (734) 936-8695 | yuecao@umich.edu |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Male |
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| 1 Month Post RT |
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