Status:
COMPLETED
Vertebral Body Sparing Craniospinal Irradiation for Pediatric Patients With Cancer of the Central Nervous System
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Conditions:
Malignant Central Nervous System Neoplasm
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief Summary
This trial studies the feasibility of using intensity modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. Intensity modulated proton therapy ...
Detailed Description
PRIMARY OBJECTIVES: I. To demonstrate the feasibility and safety of using intensity modulated proton therapy to deliver vertebral body sparing craniospinal irradiation in growing children. Ia. To re...
Eligibility Criteria
Inclusion
- Pathologic diagnosis of central nervous system malignancy requiring craniospinal irradiation.
- Signed informed consent and assent when indicated.
Exclusion
- Any contraindication to undergoing MRI (ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial cardiac valves or devices, electrical implants such as cardiac pacemakers or perfusion pumps). Metal fragments, shrapnel, or tattoos near the eye.
- Any major uncontrolled or poorly controlled current illness that would limit compliance with study requirements.
- Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.
Key Trial Info
Start Date :
December 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04276194
Start Date
December 16 2019
End Date
February 9 2024
Last Update
March 21 2024
Active Locations (2)
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1
Emory Proton Therapy Center
Atlanta, Georgia, United States, 30308
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322