Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases

NCT ID: NCT04033497

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-20
• Study Completion Date: 2028-07-01

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.

Detailed Description

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.

Conditions

Brain Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MRI

Intervention Type: DEVICE

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

Interventions

MRI

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Ayal Aizer, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayal Aizer, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ayal Aizer, MD, MHS

Role: CONTACT

aaaizer@partners.org

617-732-7560

Ivy Ricca, BA

Role: CONTACT

iricca@mgb.org

6175828927

Facility Contacts

Ayal Aizer, MD, MPH

Role: primary

aaaizer@partners.org

617-732-7560

Other Identifiers

19-191

Identifier Type: -

Identifier Source: org_study_id