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Post-Surgical Stereotactic Radiotherapy v Surgically Targeted Radiation w Gamma Tile for Brain Mets

The purpose of this research study is to compare surgical tumor removal followed by stereotactic radiotherapy (SRT) to surgical tumor removal followed by radiation therapy delivered by surgically implanted GammaTiles TM (GT)

Age & Gender

18 years ~ 99 years
Male, Female

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina

What will be asked of you

The study involves study removal of brain tumor, radiation therapy at the time of surgery, blood draws, MRI, CT scans and questionnaires / assessments.

In-person visits:
7

Total length of participation:
2 years

Looking for Specific Volunteers

Able to participate:

One to four newly diagnosed brain metastases (spread from a primary cancer site to the brain)
Fluent in English (reading and writing)
Willing to avoid becoming pregnant or father children during the duration of the trial
Able to have an MRI of the head with contrast
Adequate organ function

Not eligible if:

Sensitivity to bovine (cow) derived materials including collagen products
Past radiation/surgery to the brain lesions (There are some exceptions to this rule so inquire with your doctor if this applies to you)
Patients with more than 4 newly diagnosed brain metastases or have a primary germ cell tumor, small cell carcinoma, or lymphoma.
Leptomeningeal metastasis (spread of cancer to the thin tissue that covers the brain and spinal cord or to the cerebrospinal fluid).
Patients unable to follow with the study requirements and schedule

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Colette Shen
Radiation Oncology - Chapel Hill

Study Type

Clinical or Medical
Interventional

Study Topics

Brain, Head, Nervous System
Cancer (Brain and Other Nervous System)

IRB Number

22-3346

ClinicalTrials.gov

NCT04365374

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