Summary

Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by David Piccioni, MD, PhD

Description

Summary

The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.

Official Title

A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

Details

Patients (N=600) with surgically resected (R) brain tumors of any pathology who have undergone STaRT are eligible. Data collected will include local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE's. Data will be collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULT: Data will be used to benchmark clinical outcomes of STaRT therapy and allow for comparisons to existing standard-of-care treatments. This will be the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.

Keywords

Brain Tumor, Recurrent, Brain Tumor, Brain Tumor, Primary, Brain Tumor - Metastatic, Brain Tumor, Adult: Glioblastoma, Brain Tumor, Adult Meningioma, Neoplasms, Glioblastoma, Brain Neoplasms, Meningioma, GammaTile

Eligibility

You can join if…

  1. Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
  2. Willing and able to provide informed consent and to participate in all evaluations.

You CAN'T join if...

  1. Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
  2. Major medical or psychiatric illness, which, in the investigator's opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and/or interfere with follow ups.
  3. Lack of English language fluency sufficient to allow for completion of neurocognitive and QOL tests (which are in English).

Locations

  • UCSD Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • HonorHealth Research Institute accepting new patients
    Phoenix Arizona 85027 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GT Medical Technologies, Inc.
ID
NCT04427384
Study Type
Observational [Patient Registry]
Participants
Expecting 600 study participants
Last Updated