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Evaluation of Radiobiological Effects in Skin Toxicities Head and Neck Cancer Patients With PBS Proton Therapy

NCT06183268 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-08

No results posted yet for this study

Summary

This purpose of this study is to examine skin reactions (called radiation dermatitis) that occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique technique called "Spot Delete" to see if it can reduce skin reactions for head \& neck patients treated with PBS. The investigators will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to these skin reactions. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body.

Conditions

Interventions

RADIATION

Spot Delete

The treatments plans will utilize the scripted spot delete method to remove spots from the skin rind. To ensure all relevant skin spots are removed, the "SkinSpots" structure will be a 0.5 cm rind extending inward from the skin contour within 5 cm of the CTV. Spots will be removed from this structure and optimization will continue. Optimization objectives will be utilized to spare the skin rind structure during treatment planning, in addition to deleting spots.

Sponsors & Collaborators

  • Thompson Cancer Survival Center

    lead OTHER

Principal Investigators

  • Samantha Hedrick, PhD, DABR · Thompson Proton Center, Director of Medical Physics

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-13
Primary Completion
2028-01-02
Completion
2030-01-02
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06183268 on ClinicalTrials.gov