Recruiting

Stereotactic Radiosurgery

Sponsor:

University of Chicago

Code:

NCT07767981

Conditions

Adverse Radiation Effects

Radiation Necrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This prospective observational study will investigate the relationship between the gut microbiome and adverse effects following stereotactic radiosurgery (SRS). Patients undergoing SRS as part of their standard clinical care will provide blood and stool samples before treatment and during follow-up. Samples will be analyzed to characterize fecal and blood metabolomic profiles and changes in the gut microbiome over time.

The study has two primary objectives: to determine how stereotactic radiosurgery affects the gut microbiome and associated metabolomic profiles, and to evaluate whether microbiome- and metabolite-associated features are related to the development of adverse effects following SRS. Clinical data and standard-of-care neuroimaging will be collected longitudinally to identify outcomes including radiation necrosis and other adverse radiation effects. Biological profiles from patients who develop these outcomes will be compared with those from patients who do not, as well as within individual patients over time.

The study aims to identify microbiome and metabolic signatures associated with susceptibility to adverse effects of stereotactic radiosurgery, with the long-term goal of improving risk stratification and informing future approaches to monitoring and treatment.

Conditions

Adverse Radiation Effects

Radiation Necrosis

Study ID

NCT07767981

Start date

Aug 5, 2025

Status verified date

Aug, 2026

Completion date

Sep 5, 2028

Anticipated

Primary completion date

Aug 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Admitted to the University of Chicago Medical Center
  • Receiving stereotactic radiosurgery as standard of care for their presumed diagnosis
  • Able to provide informed consent

Exclusion Criteria:

  • Anticipated survival of less than 6 months
  • Known or suspected infectious colitis within the month prior to enrollment
  • Rectal disease that prevents fecal sampling
  • Foreseeable inability to complete the study

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of Participants With Radiation Necrosis Following Stereotactic Radiosurgery [ Time Frame: From stereotactic radiosurgery through 2.5 years of follow-up ]

Central Contacts and Locations

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

More Information

Sponsor

University of Chicago

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Stereotactic Radiosurgery
  • Adverse Radiation Effects
  • Radiation Necrosis
  • Gut Microbiome
  • Microbiome
  • Metabolomics
  • Fecal Metabolomics
  • Blood Metabolomics
  • Biomarkers
  • Neurotoxicity
  • Radiation Toxicity
  • Neuro-Oncology
  • Brain Radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-08-18.