Purpose

The first goal of this project is to validate the superiority of semi-permanent marks used in conjunction with specialized light-based surface imaging (SIGRT) in an effort to phase out the use of permanent tattoos for the investigator's patients. The secondary goal of this project is to validate the superiority of specialized light-based surface imaging for daily radiation set-up compared to standard-of-care imaging methods using ionizing radiation, such as weekly port films or cone-beam CT (CBCT) scans during a radiation therapy course for breast cancer.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years
  • Biologically female
  • Ability to provide informed written consent in either English or Spanish
  • Surgical pathology and staging scans must demonstrate Ductal carcinoma in situ (DCIS) or invasive breast cancer, Stages 0, 1, 2, and 3
  • Patient will undergo adjuvant radiation therapy as a part of multimodality breast cancer treatment with plans for tangent field radiation treatment with or without loco-regional lymph node targeting, based on the clinical judgement of the treating physician
  • Willingness to maintain temporary skin markings for a part of their of radiation therapy duration
  • Absence of any conditions that may affect ability to have either tattoos or skin markings, as discussed in

Exclusion Criteria

Exclusion Criteria:

- Age < 18 years

- Biologically non-female

- Inability or unwillingness of subject to give written informed consent

- Patients found at presentation to have very locally-advanced cancer (e.g. inflammatory breast cancer) or metastatic breast cancer (Stage 4)

- Patients that will be treated with a deep-inspiration breath hold technique (typically younger patients being treated for left-sided tumors)

- Current pregnancy, as this is a contraindication to receiving radiation therapy

- History of prior radiotherapy to the chest wall or torso

- Known allergy / sensitivity to standard medical marking tattoo ink (by design non-toxic, low-allergy), skin marking paint, or medical tape (e.g. Tegaderm)

- Active drug or alcohol use or dependence evidenced by patient record and/or self-report that, in the opinion of the investigator, would interfere with adherence to daily radiation therapy

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Subjects undergoing breast radiotherapy At the time of CT simulation study participants will receive temporary skin markings to be covered in clear medical grade tape. Light-based surface imaging will be used to determine alignment between the patient and the radiation machine. Radiation treatment will proceed as standard of care.
  • Other: Temporary skin markings
    To use temporary markings in lieu of localization tattoos.
  • Other: Surface imaging
    To use light-based surface imaging for patient positioning during radiation treatment.

Recruiting Locations

UT Health San Antonio Mays Cancer Center
San Antonio, Texas 78229
Contact:
Angela Kennedy
210-450-6490
kennedya3@uthscsa.edu

More Details

NCT ID
NCT03799523
Status
Recruiting
Sponsor
Richard Crownover

Study Contact

Carol Jenkins, RN
210-450-5924
jenkins@uthscsa.edu

Detailed Description

This study uses surface imaging for breast patients to standardize or normalize planning position & minimize variability of port films thus reducing systematic error. The primary objective of this study is to demonstrate the superiority of using surface imaging to combine an ideally gated treatment planning CT and verification images timed to the breathing cycle, quantified as the total within-subject variation of the measured location relative to current methods of radiation delivery not using this approach. The secondary objective is to demonstrate the superiority of specialized light-based surface imaging for daily radiation set-up without tattoos compared to standard-of-care methods with regard to the total within-subject variation of the measured location determined by weekly port films during a course of radiation for breast cancer.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.