NCT03281889

Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation

Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation. The radiation involved in this study is: -Proton Radiation

Detailed description

This research study is a Pilot Study to determine whether using proton therapy in participants that require craniospinal radiation (whole brain and spinal cord radiation therapy) with sparing of the bony spine will work. This is the first time investigators are examining bone sparing proton therapy in pediatric craniospinal radiation. The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for this specific disease but it has been approved for other uses. In this research study, the investigators are studying proton radiation in participants that require craniospinal radiation. The standard of care for this procedure is photon radiation, which is very similar to proton radiation. The investigators believe that the precision of proton radiation may help to reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

Conditions

• Brain Tumor

Interventions

Type	Name	Description
RADIATION	Proton Beam	precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

Timeline

• Start date: 2018-01-04
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2017-09-13
• Last updated: 2026-03-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study