Status:
COMPLETED
Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 perm...
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 st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03799523
Start Date
January 16 2019
End Date
February 22 2024
Last Update
August 9 2024
Active Locations (1)
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1
UT Health San Antonio Mays Cancer Center
San Antonio, Texas, United States, 78229