Clinical trial · Interventional
Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos
Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos for Localization of Adjuvant Radiotherapy Fields in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Reliable and consistent method of UV Tattoo application was not able to be achieved.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Image Disturbance | — | UNRESOLVED | — |
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UV fluorescent ink | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 - UV ink
- description
- Radiotherapy tattoos will be applied using an invisible UV fluorescent ink that can only be detected while illuminated with a special ultraviolet flashlight.
- interventionNames
- Other: UV fluorescent ink
- type
- NO_INTERVENTION
- label
- Arm 2 - Black ink
- description
- Radiotherapy tattoos will be applied using standard black ink.
Primary outcomes (1)
- measure
- Change in Body-image scale score
- timeFrame
- Day 0, Week 3, Week 12
- description
- Mean BIS scores at each time point will be calculated along with standard deviation and will be compared using the student t-test.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available