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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Ayal Aizer, MD, MHS
aaaizer@partners.org
617-732-7560
Backup
Ivy Ricca, BA
iricca@mgb.org
6175828927
Time Frame
Start Date: 2019-08-20
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 101
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov