Recruiting

Pencil Beam Scanning Proton Therapy

Sponsor:

Thompson Cancer Survival Center

Code:

NCT06006806

Conditions

Breast Cancer

Breast Cancer Stage II

Breast Cancer Stage III

Breast Cancer Stage I

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pencil Beam Scanning Proton Therapy

Study Details

Brief 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 breast patients treated with PBS. They 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. The clinical team uses this CT scan to find the best placement for the protons. The "Spot Delete" method prevents protons from stopping in the skin, which is thought to cause skin redness.

Conditions

Breast Cancer

Breast Cancer Stage II

Breast Cancer Stage III

Breast Cancer Stage I

Study ID

NCT06006806

Start date

Jul 7, 2023

Status verified date

Apr, 2025

Completion date

Jul 7, 2030

Anticipated

Primary completion date

Jul 7, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The patient must consent to be in the study and must have signed an approved consent form conforming to federal and institutional guidelines.
  • Patients must be equal to or greater than 18 years old.
  • The patient must have stage 0, I, II, or III breast cancer
  • On histological examination, the tumor must be ductal carcinoma in-situ (DCIS) or invasive adenocarcinoma of the breast
  • Surgical treatment of the breast must have been lumpectomy or mastectomy
  • Patients must have an estrogen receptor (ER) analysis performed on the primary tumor
  • Progesterone (PgR) analysis is desired but not mandatory
  • No serious health conditions as determined by physician that would impact ability to complete treatment or impact skin in the area of treatment

Exclusion Criteria:

  • Stage IV breast cancer
  • Non-epithelial breast malignancies such as sarcoma or lymphoma
  • Paget's disease of the nipple
  • Prior breast or thoracic radiation therapy (RT) for any condition.
  • Collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  • Pregnancy or lactation
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Interventions

Pencil Beam Scanning Proton Therapy

Part of the normal proton therapy process is to have a CT scan (called a CT simulation) performed that is used to create a proton treatment plan. A proton treatment plan is a computer model of the proton beam that is used to calculate where the protons will go inside the body. During the treatment planning process, the clinical team works to find the best possible placement of the protons. This study uses a process called "Spot Delete" to keep protons from stopping in the skin, which is believed to be related to skin reddening. Spot Delete is a software application that was developed at the Thompson Proton Center and is used in the treatment planning process.

Primary outcome measure

  • Reduction in Radiation Dermatitis [ Time Frame: weekly assessments over 10 weeks ]

Central Contacts and Locations

Central contacts

Samantha Hedrick

865-862-1600shedrick@covhlth.com

Chester Ramsey, PhD

865-331-3161cramsey@covhlth.com

Locations

Thompson Proton Center

Recruiting

Knoxville, Tennessee, United States, 37909

Contacts

Casey Mastio-Partridge, BS, MLS

865-331-8216cmastio@covhlth.com

Jessica M Severt, RN, BSN

865-331-4966jsevert@covhlth.com

Principal Investigator:

Samantha Hedrick, Ph.D

More Information

Sponsor

Thompson Cancer Survival Center

Last update posted

Apr 8, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thompson Cancer Survival Center on 2025-04-08.