RECRUITING

UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases

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Conditions

Brain Metastases, AdultNeurocognitive FunctionCancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this proposal, the investigators introduce advanced diffusion and volumetric imaging techniques along with innovative, automated image parcellation methods to identify critical brain regions, incorporate into cognitive-sparing SRS, and analyze biomarkers of radiation response. This work will advance the investigators' understanding of neurocognitive changes after brain SRS and help create interventions that preserve cognitive-function in brain metastases patients.

Official Title

UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal Regions

Quick Facts

Study Start:2019-05-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04343157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients 18 years or older
  2. 2. One to three brain metastases targets, all smaller than 3 cm in diameter (intact or resected tumor bed)
  3. 3. Eastern cooperative Oncology Group (ECOG) performance status 0-2 (score of 0, no symptoms; 1, mild symptoms; 2, symptomatic, \<50% in bed during the day)
  4. 4. Ability to answer questions and follow commands via neurocognitive testing
  5. 5. Estimated life expectancy greater than 6 months
  6. 6. Pathologic confirmation of extracerebral tumor site (eg, lung, breast, prostate) from either the primary site or a metastatic lesion
  7. 7. Willingness/Ability to undergo brain MRI scans
  8. 8. Able to give informed consent
  1. 1. Pregnant or nursing women
  2. 2. Women of childbearing potential unwilling to use adequate contraception
  3. 3. Inability to complete a magnetic resonance imaging scan with contrast
  4. 4. Tumor directly invading the critical area to be spared (for example a patient with tumor invading a critical white matter tract; ineligible for cognitive-sparing)
  5. 5. Planned chemotherapy during SRS (on the day of SRS)
  6. 6. Previous whole brain radiation therapy
  7. 7. Leptomeningeal metastases (ineligible for SRS)
  8. 8. Metastases from primary germ cell tumor, small cell carcinoma, or primary CNS lymphoma (ineligible for SRS)

Contacts and Locations

Study Contact

Sheila Medina
CONTACT
858-822-6575
s4medina@health.ucsd.edu

Principal Investigator

Jona Hattangadi-Gluth, MD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

Moores Cancer Center
San Diego, California, 92037
United States

Collaborators and Investigators

Sponsor: Jona Hattangadi-Gluth

  • Jona Hattangadi-Gluth, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2019-05-01
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Brain Metastases, Adult
  • Neurocognitive Function
  • Cancer