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NCT Number: NCT04246879

MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

Subjects undergo one additional delayed MRI sequence

Primary outcomes

  1. number of positive MRI sequences along with positive tumor biopsies

    Time frame: baseline

    true tumor will be detected by delayed MRI as determined by biopsy

  2. number of negative MRI sequences along with negative tumor biopsies

    Time frame: baseline

    absence of tumor will be detected by delayed MRI as determined by biopsy

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Jan 29, 2020
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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