Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases
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ClinicalTrials.gov Identifier: NCT04033497 |
Recruitment Status :
Recruiting
First Posted : July 26, 2019
Last Update Posted : September 25, 2023
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Condition or disease | Intervention/treatment | Phase |
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Brain Tumor | Device: MRI | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 53 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Treatment Response Assessment Maps (TRAMs) in the Delineation of Radiation Necrosis From Tumor Progression After Stereotactic Radiation in Patients With Brain Metastases: A Prospective Study |
Actual Study Start Date : | August 20, 2019 |
Estimated Primary Completion Date : | July 1, 2024 |
Estimated Study Completion Date : | July 1, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: TRAMs I
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Device: MRI
Magnetic Resonance Imaging will generate imaging of the brain to identify recurrence of tumor. |
- Sensitivity [ Time Frame: Within 3 months of study enrollment ]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
- Specificity [ Time Frame: Within 3 months of study enrollment ]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
- Positive predictive value [ Time Frame: Within 3 months of study enrollment ]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
- Negative predictive value [ Time Frame: Within 3 months of study enrollment ]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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants must have a histologically or cytologically confirmed solid malignancy of extracranial origin and radiographic evidence of at least one brain metastasis for which stereotactic radiation was utilized in the past. Patients with intracranial pathologic confirmation of a malignancy which originated extracranially but for which extracranial disease has not been biopsied are eligible.
- Participants must have an enlarging lesion in the brain at least 4 months after prior stereotactic radiation to the same site for which neurosurgical resection is planned as routine standard of care.
- Participants must be age 18 years or older.
- Participants must be willing to undergo study procedures.
- The effects of gadolinium / other MRI-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
- Participants must possess the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Participants who have a contraindication to MRI (e.g. non compatible implanted metallic device for which MRI is absolutely contraindicated).
- Participants who have chronic kidney disease stage IV-V or end stage renal disease.
- Participants with a history of anaphylactic reactions to gadolinium.
- Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033497
Contact: Ayal Aizer, MD, MHS | 617-732-7560 | aaaizer@partners.org | |
Contact: Ivy Ricca, BA | 6175828927 | iricca@mgb.org |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Ayal Aizer, MD, MPH 617-732-7560 aaaizer@partners.org | |
Principal Investigator: Ayal Aizer, MD, MPH |
Principal Investigator: | Ayal Aizer, MD | Dana-Farber Cancer Institute |
Responsible Party: | Ayal Aizer, MD, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT04033497 |
Other Study ID Numbers: |
19-191 |
First Posted: | July 26, 2019 Key Record Dates |
Last Update Posted: | September 25, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | Data can be shared no earlier than 1 year following the date of publication |
Access Criteria: | 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Brain Tumor |
Brain Neoplasms Necrosis Neoplasms Pathologic Processes Central Nervous System Neoplasms |
Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |