Breast Cancer FemaleSPOTNCT03131011
Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos
A study testing UV fluorescent ink in people with Breast Cancer Female and Body Image Disturbance, run by CancerCare Manitoba at 1 site in Canada.
Trial summary
A phase II prospective, randomized control trial assessing the impact of "invisible ink" ultra-violet (UV) tattoo ink versus conventional black tattoo ink for radiotherapy treatment localization on the quality of life of breast cancer patients undergoing adjuvant radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer Female, Body Image Disturbance
- What is being tested?
- UV fluorescent ink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2017to 23 Apr 2019
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female age 18-60.
- Histologically confirmed early stage invasive ductal or lobular carcinoma of a single breast (T1N0M0-T2N0M0) or DCIS/LCIS (TisNxMx or TisN0M0) of a single breast.
- Deemed fit to undergo adjuvant radiotherapy to their breast by their supervising radiation oncologist.
- Able to provide written informed consent.
- Must be willing to be contacted by e-mail and have a valid e-mail account to complete follow up self-reported body image scale questionnaires.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Intact skin at site of standard radiotherapy tattoos. Must have access to a computer and be able and willing to comply with requirements of the protocol.
Who cannot join
- History of any prior radiotherapy courses to the chest or abdomen.
- Metastatic disease.
- Node positive breast cancer.
- Bilateral breast cancer or bilateral DCIS/LCIS.
- Deep-inspiration breath hold radiotherapy technique.
- Unable or unwilling to comply with the requirements of the protocol as assessed by the study investigator or coordinator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos for Localization of Adjuvant Radiotherapy Fields in Breast Cancer Patients
A phase II prospective, randomized control trial assessing the impact of "invisible ink" ultra-violet (UV) tattoo ink versus conventional black tattoo ink for radiotherapy treatment localization on the quality of life of breast cancer patients undergoing adjuvant radiotherapy. The effect of tattoo type on quality of life will be measured objectively using the externally validated body-image satisfaction (BIS) scale as the primary outcome of interest, with secondary endpoints including: accuracy/reproducibility of radiotherapy setup using the invisible ink tattoos, resource impact requirements, and clinical feasibility. A sample size of 60 patients is planned (30 per study arm) with an anticipated accrual period of 18 months.
Read the detailed description
Breast cancer patients ages 18-60 who are planned for adjuvant radiotherapy and who meet all inclusion/exclusion criteria will be offered voluntary participation in this trial. Recruitment will be open for approximately 18 months; it is anticipated that 1-2 patients will be recruited per week until the planned sample size is met. Participants will be stratified into three groups depending on their self-reported baseline Body-image satisfaction (BIS) score and will then be randomly allocated to receive conventional dark ink or UV fluorescent tattoos using permutated block randomization (4 patients per block) to ensure balance of BIS baseline average between study arms.
The investigators focus is to improve the current tattooing technique for breast cancer patients by introducing an alternate method that takes the patient's psychological perceptions of tattooing into account while first and foremost, continuing to guarantee that the current standard of accuracy in treatment delivery is maintained or improved. The investigators goal of decreasing the psychological effect of permanent radiotherapy tattoos aligns with CancerCare Manitoba's mission to improve the outcomes and quality of life for Manitobans with cancer.
- Conditions
- Breast Cancer Female, Body Image Disturbance
- Being tested
- UV fluorescent ink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV fluorescent inkOther
The use of UV tattoo ink results in a tattoo that is visible only under an ultraviolet light. Conventional black tattoo ink is replaced with UV ink for the application of radiotherapy "dot" tattoos. Handheld UV flashlights are used to make the tattoos visible for use during radiotherapy treatment set-up.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - UV ink | Experimental | Radiotherapy tattoos will be applied using an invisible UV fluorescent ink that can only be detected while illuminated with a special ultraviolet flashlight. Receives: Other: UV fluorescent ink |
| Arm 2 - Black ink | No intervention | Radiotherapy tattoos will be applied using standard black ink. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body-image scale score
Mean BIS scores at each time point will be calculated along with standard deviation and will be compared using the student t-test.
Measured: Day 0, Week 3, Week 12
Secondary outcomes (4)
Set-up Accuracy
Set-up accuracy will be assessed using orthogonal image sets from fractions 1, 2, 3 \& one day treatment week 2 for each participant. Pre-imaging couch angle, vertical, longitudinal and lateral positions will be compared to the post-imaging values and evaluated based on our departmental couch adjustment tolerances for image-guided radiation therapy.
Measured: Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)
Resource Requirements (Tattooing procedure length)
The average time(Min) it takes to complete the tattooing procedure during simulation will be collected and compared between the two arms.
Measured: Day 0 Simulation appointment, Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)
Resource Requirements (Treatment set-up procedure length)
The average time(Min) it takes to complete daily treatment set-up will be collected and compared between the two arms.
Measured: Day 0 Simulation appointment, Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)
Radiation Therapist Evaluation Survey of UV Tattoo Method
Clinical practicability will be evaluated qualitatively through feedback from radiation therapists through a survey measuring their satisfaction with the UV tattooing method.
Measured: Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start10 Sep 2017
- Primary completion23 Apr 2019
- Study completion23 Apr 2019
Why it stopped: Reliable and consistent method of UV Tattoo application was not able to be achieved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- CancerCare Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian Kim, MD, MSc, Principal investigator, CancerCare ManitobaErin V Toews, B.Sc., RTT, Principal investigator, CancerCare Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131011
- Sponsor's protocol ID
- RRIC 2017-011
- Acronym
- SPOT
- Status last verified
- Jul 2018
- First submitted
- 13 Apr 2017
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos for Localization of Adjuvant Radiotherapy Fields in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03131011
- Acronym / sponsor ID
- SPOT / RRIC 2017-011
- Conditions
- Breast Cancer Female, Body Image Disturbance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reliable and consistent method of UV Tattoo application was not able to be achieved.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- CancerCare ManitobaUniversity, hospital or other
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 27 Apr 2017 (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.
A phase II prospective, randomized control trial assessing the impact of "invisible ink" ultra-violet (UV) tattoo ink versus conventional black tattoo ink for radiotherapy treatment localization on the quality of life of breast cancer patients undergoing adjuvant radiotherapy. The effect of tattoo type on quality of life will be measured objectively using the externally validated body-image satisfaction (BIS) scale as the primary outcome of interest, with secondary endpoints including: accuracy/reproducibility of radiotherapy setup using the invisible ink tattoos, resource impact requirements, and clinical feasibility. A sample size of 60 patients is planned (30 per study arm) with an anticipated accrual period of 18 months.
Detailed description
Breast cancer patients ages 18-60 who are planned for adjuvant radiotherapy and who meet all inclusion/exclusion criteria will be offered voluntary participation in this trial. Recruitment will be open for approximately 18 months; it is anticipated that 1-2 patients will be recruited per week until the planned sample size is met. Participants will be stratified into three groups depending on their self-reported baseline Body-image satisfaction (BIS) score and will then be randomly allocated to receive conventional dark ink or UV fluorescent tattoos using permutated block randomization (4 patients per block) to ensure balance of BIS baseline average between study arms.
The investigators focus is to improve the current tattooing technique for breast cancer patients by introducing an alternate method that takes the patient's psychological perceptions of tattooing into account while first and foremost, continuing to guarantee that the current standard of accuracy in treatment delivery is maintained or improved. The investigators goal of decreasing the psychological effect of permanent radiotherapy tattoos aligns with CancerCare Manitoba's mission to improve the outcomes and quality of life for Manitobans with cancer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - UV ink | Experimental | Other: UV fluorescent inkRadiotherapy tattoos will be applied using an invisible UV fluorescent ink that can only be detected while illuminated with a special ultraviolet flashlight. |
| Arm 2 - Black ink | No intervention | –Radiotherapy tattoos will be applied using standard black ink. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female age 18-60.
- Histologically confirmed early stage invasive ductal or lobular carcinoma of a single breast (T1N0M0-T2N0M0) or DCIS/LCIS (TisNxMx or TisN0M0) of a single breast.
- Deemed fit to undergo adjuvant radiotherapy to their breast by their supervising radiation oncologist.
- Able to provide written informed consent.
- Must be willing to be contacted by e-mail and have a valid e-mail account to complete follow up self-reported body image scale questionnaires.
Key exclusion criteria (6 listed)
- History of any prior radiotherapy courses to the chest or abdomen.
- Metastatic disease.
- Node positive breast cancer.
- Bilateral breast cancer or bilateral DCIS/LCIS.
- Deep-inspiration breath hold radiotherapy technique.
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 |
|---|---|---|
| UV fluorescent inkThe use of UV tattoo ink results in a tattoo that is visible only under an ultraviolet light. Conventional black tattoo ink is replaced with UV ink for the application of radiotherapy "dot" tattoos. Handheld UV flashlights are used to make the tattoos visible for use during radiotherapy treatment set-up. | Other | Arm 1 - UV ink |
Primary outcome
Change in Body-image scale score
Time frame: Day 0, Week 3, Week 12
Mean BIS scores at each time point will be calculated along with standard deviation and will be compared using the student t-test.
4 secondary outcomes
Set-up Accuracy
Time frame: Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)
Resource Requirements (Tattooing procedure length)
Time frame: Day 0 Simulation appointment, Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)
Resource Requirements (Treatment set-up procedure length)
Time frame: Day 0 Simulation appointment, Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)
Radiation Therapist Evaluation Survey of UV Tattoo Method
Time frame: Week 13
Results and safety
The study was stopped early (reason given: Reliable and consistent method of UV Tattoo application was not able to be achieved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Julian Kim, MD, MSc principal investigator
CancerCare Manitoba
Erin V Toews, B.Sc., RTT principal investigator
CancerCare Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UV fluorescent ink in people with Breast Cancer Female and Body Image Disturbance, run by CancerCare Manitoba at 1 site in Canada.
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 6 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: stopped early, as of the sponsor's last update on 13 Jun 2019. 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 Canada. 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 was stopped early (reason given: Reliable and consistent method of UV Tattoo application was not able to be achieved.). Results are not available in the source record.
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?
Change in Body-image scale score (time frame: Day 0, Week 3, Week 12). 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 13 Jun 2019.