Microbiome Determinants of Adverse Effects of Stereotactic Radiosurgery

Conditions

• Adverse Radiation Effects
• Radiation Necrosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

First listed

Aug 17, 2026

Start date

Aug 5, 2025

Status verified

Aug 2026

Primary completion

Aug 5, 2027

Completion

Sep 5, 2028

Study Design

Enrollment

150 participants (estimated)

Primary Outcome Measure

Radiation Injury [ Time Frame: From enrollment to 2.5 year follow-up ]

Locations (1)

Find similar trials in Chicago, IL

Related Studies

• REMASTer: REcurrent Brain Metastases After SRS Trial
  Recruiting · Monteris Medical · Los Angeles, California
• TENS of Auricular Vagal Nerve for Radiation Necrosis
  Not Yet Recruiting · Virginia Commonwealth University · Richmond, Virginia