Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy

NCT03799523 | Completed DMC

• 2 other identifiers: CTMS# 18-013518-769H
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Position measurement from Port films.

  Distance measured (centimeters) from the planned position of radiotherapy to the actual position of radiotherapy on weekly port films. Port films are x-rays of the treatment field which are done to ensure that the patient and the radiation machine are properly aligned to each other. Weekly port films will be obtained for the duration of radiation treatment, which will be from three to five weeks in length.

  Once weekly for 3 weeks up to 5 weeks

Study Arms (1)

Subjects undergoing breast radiotherapy

EXPERIMENTAL

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; Other: Surface imaging

Interventions

Temporary skin markings OTHER

To use temporary markings in lieu of localization tattoos.

Subjects undergoing breast radiotherapy

Surface imaging OTHER

To use light-based surface imaging for patient positioning during radiation treatment.

Subjects undergoing breast radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health San Antonio Mays Cancer Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eva Galvan, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: January 10, 2019
• Study Start: January 16, 2019
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

US (1)