Table of contents
- Trial overview
- Who can participate
- What is being measured
- Study design and phase
- What the trial is trying to learn
Trial overview
The available study is an interventional trial, which means the research team gives the study treatment and then checks what happens.[1] It is authorised and planned for 22 people.[1]
The trial title says it studies the effect of 6QC-ICG on the skin of healthy volunteers and in patients with breast cancer during surgeries.[1] The brief summary explains that Part A looks at safety and tolerability on wounded skin in healthy volunteers, while Part B looks at safety and tolerability during surgery for breast conserving surgery in patients with breast cancer.[1]
Who can participate
One group in the study is healthy volunteers, who are people without the cancer being studied.[1] In this part, the treatment is applied to wounded skin to see how the skin responds.[1]
The other group is patients with breast cancer who are having breast conserving surgery.[1] This means the study is not only about healthy skin, but also about use during an operation for cancer care.[1]
Study design and phase
This is a Phase 1/2 study.[1] Phase 1 studies mainly look at safety and tolerability, while Phase 2 studies begin to explore whether the approach may help with the medical problem being studied.
The interventions listed are 6QC-ICG given as a topical application on wound and a placebo for 6QC-ICG.[1] A placebo is a comparison treatment that does not contain the active study product, and it helps researchers judge the true effect of the study treatment.
What is being measured
The main outcomes focus on local tolerability and systemic safety.[1] Local tolerability means how the treated skin area reacts, and systemic safety means whether the treatment causes effects in the rest of the body.
The study measures pain and itching using numeric rating scales, which are simple scales where people rate how strong a symptom feels.[1] It also tracks local and systemic treatment-emergent serious and non-serious adverse events, which are medical problems that appear during the study.[1]
Researchers also check vital signs, including pulse rate and blood pressure, to watch basic body functions during the study.[1] In addition, the trial includes clinical laboratory tests such as hematology, blood chemistry, and urinalysis, plus ECG measurements like heart rate, PR, QRS, QT, and QTcF.[1]
The study also records concomitant medication, which means any other medicines the participant is taking during the trial.[1]
What the trial is trying to learn
Part A is designed to learn whether a single dose of topically applied 6QC-ICG is safe and well tolerated on wounded skin in healthy volunteers.[1]
Part B is designed to learn whether the same single-dose topical use is safe and well tolerated for intraoperative visualization of residual breast cancer during breast conserving surgery.[1] In simple words, the study is asking whether 6QC-ICG can help surgeons see remaining cancer during the operation while also staying safe for the patient.[1]
