MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

Study Purpose

The purpose of this study is to test whether an additional magnetic resonance image (MRI) sequence can improve the ability to distinguish radiation damage from tumor recurrence in participants with brain metastasis who have previously been treated with stereotactic radiosurgery (SRS).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Adult patients, age ≥18.
  • - Metastatic malignancy with at least 1 brain metastasis previously treated with SRS.
  • - Patients may have also received whole brain radiation therapy (WBRT) for management of brain metastatic disease but this is not required for study participation.
  • - Patients must have been diagnosed with a metastatic solid tumor of any histological type except small cell lung cancer (SCLC), or lymphoma.
  • - Radiographic progression on post-SRS imaging at previously treated SRS site(s) - Must be a candidate for brain surgery as determined by treating neurosurgeon and/or anesthesia team.
  • - Patients must sign study-specific informed consent prior to study entry.

Exclusion Criteria:

  • - Poor surgical candidate as determined by treating neurosurgeon and/or anesthesia team.
- Unable to undergo contrasted MRI (e.g. incompatible medical device, inadequate renal function per standard institutional clinical protocol, contrast allergy) - Small cell lung cancer (SCLC) or lymphoma histology

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04246879
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Scott Floyd, M.D. Ph.D.
Principal Investigator Affiliation Duke Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Metastases
Arms & Interventions

Arms

Experimental: MRI

Interventions

Other: - MRI

Subjects undergo one additional delayed MRI sequence

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University Health System, Durham, North Carolina

Status

Recruiting

Address

Duke University Health System

Durham, North Carolina, 27710

Site Contact

Eileen Duffy, BNS RN OCN

[email protected]

919-668-3726

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