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

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ClinicalTrials.gov Identifier: NCT03799523
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Richard Crownover, The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment
Breast Cancer Other: Temporary skin markings Other: Surface imaging

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.

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Position measurement from Port films. [ Time Frame: Once weekly for 3 weeks up to 5 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Females with Ductal carcinoma in situ (DCIS) or invasive breast cancer, stages 0,1, 2 & 3.
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799523


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

Locations
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United States, Texas
UT Health San Antonio Mays Cancer Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Angela Kennedy    210-450-6490    kennedya3@uthscsa.edu   
Principal Investigator: Richard Crownover, MD         
Sponsors and Collaborators
Richard Crownover
Investigators
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Principal Investigator: Richard Crownover, MD Principal Investigator

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Responsible Party: Richard Crownover, Clinical Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT03799523     History of Changes
Other Study ID Numbers: CTMS# 18-0135
18-769H ( Other Identifier: UT Health Science Center Institutional Review Board )
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No