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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
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This research study is investigating the value of an imaging study of the brain called an MRI (which stands for magnetic resonance imaging), utilized in unique way, to delineate whether the tumor has recurred or whether radiation changes have occurred after a brain metastasis treated with focused radiation has enlarged.
This research study is a Phase II clinical trial.
In this research study, the investigators are utilizing MRIs of the brain with additional post-imaging processing (called Treatment Response Assessment Maps or TRAMs) to try to delineate tumor recurrence from radiation changes. The investigators hope to understand whether such a test may allow future patients to avoid resection entirely.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAMs I | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Device | Magnetic Resonance Imaging will generate imaging of the brain to identify recurrence of tumor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | The sensitivity along with 95% exact binomial confidence interval of pre-operative treatment response assessment maps for the identification of viable tumor relative to the gold standard of pathologic review | Within 3 months of study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | The specificity along with 95% exact binomial confidence interval of pre-operative treatment response assessment maps for the identification of viable tumor relative to the gold standard of pathologic review | Within 3 months of study enrollment |
| Positive predictive value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayal Aizer, MD, MHS | Contact | 617-732-7560 | aaaizer@partners.org | |
| Ivy Ricca, BA | Contact | 6175828927 | iricca@mgb.org |
| Name | Affiliation | Role |
|---|---|---|
| Ayal Aizer, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Data can be shared no earlier than 1 year following the date of publication
BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The positive predictive value along with 95% exact binomial confidence interval of pre-operative treatment response assessment maps for the identification of viable tumor relative to the gold standard of pathologic review |
| Within 3 months of study enrollment |
| Negative predictive value | The negative predictive value along with 95% exact binomial confidence interval of pre-operative treatment response assessment maps for the identification of viable tumor relative to the gold standard of pathologic review | Within 3 months of study enrollment |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |