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.

Category

IRB Number
20180769HU
NCT Number
NCT03799523
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Local Recruitment Point of Contact
Carol Jenkins
450-5924
jenkinsca@uthscsa.edu

Principal Investigator
Eva Galvan

Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Eva Galvan
+1 (210) 450-1093
galvane@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



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

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
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)
Condition
  • Breast Cancer

    • Arm Groups

    ArmDescriptionIntervention
    Experimental

    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.

    •