NCT07095114招募中不适用
A Phase I/II Study of Disappearing Markers for Daily Radiation Treatment Delivery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety of Magic Ink
研究概览
简要总结
The goal of this clinical trial is to learn if tattoos applied with Magic Ink is as safe as commercially available standard tattoo ink for the purpose of radiation in women with breast cancer undergoing radiation treatment. The main questions are:
- Is the Magic Ink as safe as standard tattoo ink
- Does Magic Ink continue to function and remain visible for radiation therapists during the treatment Participants will be consented and given a skin assessment. Once enrolled participants will be administered the Magic Ink tattoo instead of the standard tattoo ink in preparation for their radiation treatment. Participants will also complete a survey regarding body image. Skin assessment will occur again after the first week of radiation and at 3 months later. Throughout the radiation therapy the medical physicist will complete surveys about ease of set-up of the equipment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant must have histologically or cytologically confirmed stage 0 ductal carcinoma in situ (DCIS), I, II or III breast cancer and be planning to undergo radiation therapy (RT) after surgery
- •Participants must be 18 years of age or older
- •Participant must be able to understand a written informed consent document and be willing to sign it
- •Participant must be assigned female at birth
- •Participant must have a Karnofsky performance score of greater than or equal to 70%
- •Women of child bearing potential must agree to avoid becoming pregnant through defined periods during the course of RT and must meet one of the following:
- •Surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy
- •Post-menopausal, defined as no menses for at least 12 months prior to the screening visit without alternative medical causation
- •Agree to practice true abstinence from sexual intercourse
- •Not in a sexual relationship in which the may become pregnant (i.e., same-sex relationship)
- •If they are childbearing potential, agree to use at least one highly effective and at least one additional method of contraception.
- •For the first six participants only: Participant must have a Fitzpatrick Skin Tone Scale of 5 or 6
排除标准
- •Participants who have received prior radiation treatment to the affected breast.
- •Participants with a history of allergic reaction or hypersensitivity attributed to any tattoo ink
- •Participants with active chronic skin diseases such as psoriasis. Participants with inactive or controlled skin diseases are eligible for this study
- •Participants that are pregnant or breastfeeding. If a participant wishes to participate in this study, breastfeeding should be discontinued
- •Participants with a BMI greater than 44.5 as calculated within six months prior to the starting of the study. If there are multiple BMI measurements available in the chart, the most recent will be used to determine eligibility.
研究组 & 干预措施
Magic Ink tattoo
Experimental
Magic Ink tattoo ink which is only visible when exposed to ultraviolet light will be used to mark radiation guidance
干预措施: Magic Ink (Other)
结局指标
主要结局
Safety of Magic Ink
时间窗: 3 months after completion of Radiation Therapy
Number of participants with treatment related adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
次要结局
- Efficacy of Magic Ink(3 months after the completion of Radiation Therapy)
- Body Image Score(3 months after the completion of Radiation Therapy)
研究者
Michael Dominello
Principal Investigator
Barbara Ann Karmanos Cancer Institute
研究点 (2)
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