NEAT Non-Permanent Alignment Tattoos for Breast Cancer Radiotherapy

  • Research type

    Research Study

  • Full title

    NEAT - Non-Permanent Alignment Tattoos for Breast Cancer Radiotherapy. A randomised controlled trial investigating the efficacy of using non-permanent ink and micropigmentation technology for radiotherapy alignment marks versus permanent-ink tattoos for breast cancer radiotherapy.

  • IRAS ID

    273150

  • Contact name

    Sairanne Wickers

  • Contact email

    sairanne.wickers@nhs.net

  • Sponsor organisation

    University College London

  • Duration of Study in the UK

    2 years, 6 months, 0 days

  • Research summary

    Permanent tattooing is the most common method of skin marking for patient positioning during a radiotherapy treatment course. 3-6 tattoos of green/blue colour, approximately 1-2 mm in diameter are applied near to the treatment site with permanent Indian tattoo ink and a lancing needle. Once the radiotherapy course is complete, they are defunct of purpose and are linked to poor body image and act as a constant reminder of cancer diagnosis and treatment. These radiotherapy alignment tattoos can be very difficult to see on dark skin tones, potentially reducing the accuracy.

    Non-permanent ink and micropigmentation technology (a hand held medical device that implants non-permanent pigment) are widely used in the medical field. One example is applying pigment to the reconstructed nipple areola following mastectomy and breast reconstruction. These inks are not permanent and need to be periodically reapplied when used for cosmetic correction, as they fade. The non-permanent inks are available in a range of natural skin tones and are visible on darker skin tones.

    Pen marks may be used instead of the permanent radiotherapy tattoos but can spread and fade during a treatment course and make the radiotherapy less accurate. Using pen marks instead of tattoos can also impact the ability of a patient to wash easily during the many weeks of a treatment course. For these reasons, an alternative to permanent tattoos is not routinely offered to patients.

    This study aims to evaluate the accuracy of using non-permanent ink for patient alignment marks during radiotherapy, evaluated with the standard imaging that is acquired to verify accurate positioning during the treatment course. Patients will be randomised 1:1 to permanent or non-permanent skin marks. Important secondary outcomes will be the impact on body image, and the duration (months) for the non-permanent marks to become invisible.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    22/WM/0138

  • Date of REC Opinion

    8 Jul 2022

  • REC opinion

    Further Information Favourable Opinion