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

NCT ID: NCT03799523

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-16
• Study Completion Date: 2024-02-22

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Temporary skin markings

Intervention Type: OTHER

To use temporary markings in lieu of localization tattoos.

Surface imaging

Intervention Type: OTHER

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

Interventions

Temporary skin markings

To use temporary markings in lieu of localization tattoos.

Intervention Type: OTHER

Surface imaging

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

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Galvan, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

UT Health San Antonio Mays Cancer Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

18-769H

Identifier Type: OTHER

Identifier Source: secondary_id

CTMS# 18-0135

Identifier Type: -

Identifier Source: org_study_id