Breast CancerNCT03799523
Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy
A study testing Temporary skin markings and Surface imaging in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Temporary skin markings and Surface imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2019to 22 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health San Antonio Mays Cancer Center
San Antonio, Texas, 78229
About this study
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.
Read the 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
- Being tested
- Temporary skin markings, Surface imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary skin markingsOther
To use temporary markings in lieu of localization tattoos.
Surface imagingOther
To use light-based surface imaging for patient positioning during radiation treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Temporary skin markings; Other: Surface imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once weekly for 3 weeks up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start16 Jan 2019
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Galvan, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799523
- Sponsor's protocol ID
- CTMS# 18-0135
- Other IDs
- 18-769H
- Status last verified
- Aug 2024
- First submitted
- 19 Nov 2018
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy
- ClinicalTrials.gov ID
- NCT03799523
- Acronym / sponsor ID
- CTMS# 18-0135
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing breast radiotherapy | Experimental | Other: Temporary skin markings, Other: Surface imagingAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary skin markingsTo use temporary markings in lieu of localization tattoos. | Other | Subjects undergoing breast radiotherapy |
| Surface imagingTo use light-based surface imaging for patient positioning during radiation treatment. | Other | Subjects undergoing breast radiotherapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Galvan, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary skin markings and Surface imaging in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Position measurement from Port films. (time frame: Once weekly for 3 weeks up to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.