Recruiting

MRI

Sponsor:

Brigham and Women's Hospital

Code:

NCT04033497

Conditions

Brain Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI

Study Details

Brief summary:

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.

Conditions

Brain Tumor

Study ID

NCT04033497

Start date

Aug 20, 2019

Status verified date

Aug, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 via ink on paper or via an electronic signature medium such as Adobe Sign.

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.

Study Design

Enrollment

101 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: TRAMs I

  • Magnetic resonance imaging (MRI)-based treatment response assessment maps (TRAMs)
  • Patients with an enlarging lesion in the site of a brain metastasis treated with stereotactic radiation for which neurosurgical resection is planned will undergo preoperative TRAMs

Interventions

MRI

Magnetic Resonance Imaging will generate imaging of the brain to identify recurrence of tumor.

Primary outcome measure

  • Sensitivity [ Time Frame: Within 3 months of study enrollment ]

Central Contacts and Locations

Central contacts

Ayal Aizer, MD, MHS

617-732-7560aaaizer@partners.org

Marciana F Johnson, MPH

6175828335mjohnson71@mgb.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ayal A Aizer, MD, MHS

617-732-7560aaaizer@partners.org

Principal Investigator:

Ayal A Aizer, MD, MHS

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ayal Aizer, MD, MHS

617-732-7560aaaizer@partners.org

Principal Investigator:

Ayal Aizer, MD, MHS

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 9, 2026

Last verified

Aug, 2026

Keywords

  • Brain Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-09-09.