Overview
- Penn Medicine has opened recruitment this fall 2026 for a Phase I pilot that will enroll about 10 patients with recurrent, unresectable head and neck cancer at the Roberts Proton Therapy Center.
- Participants will receive five ConformalFLASH® proton treatments completed in under two weeks, with each beam delivered in less than one second to test the ultra‑high‑dose 'FLASH' approach.
- The trial uses IBA’s ConformalFLASH® platform, which is being studied under an FDA Investigational Device Exemption and is sponsored by Ion Beam Applications S.A.
- The primary goal is to assess safety and feasibility in humans by closely tracking treatment‑related adverse events and collecting detailed quality‑of‑life and patient‑reported outcomes.
- The study builds on Penn’s canine FLASH work and earlier human 'shoot‑through' trials for bone metastases; if safe, the team plans larger efficacy studies but wider use will require equipment upgrades and further testing.