Confirming the Accuracy of Endoscopic Marking Using a New Marker, a Novel Luminomarker, in Lesion… (NCT07380867) | Clinical Trial Compass
By InvitationNot Applicable
Confirming the Accuracy of Endoscopic Marking Using a New Marker, a Novel Luminomarker, in Lesion Marking Before Colorectal Cancer Surgery.
South Korea30 participantsStarted 2025-12-22
Plain-language summary
Early-stage lesions are difficult to identify intraoperatively during colorectal cancer surgery. Therefore, preoperative lesion marking using a colonoscopic approach is crucial to confirm the location and extent of resection during surgery. Preoperative lesion location can help determine the optimal extent of resection, thereby increasing the accuracy of colorectal surgery. This is particularly true for cases requiring surgery after early-stage colorectal cancer or endoscopic tumor resection. Therefore, preoperative marking with indocyanine green (IDG) allows for laparoscopic identification of the lesion. This is crucial because it allows for precise lesion location, thereby enhancing surgical accuracy and preventing the need for unnecessary additional resections.
Who can participate
Age range
19 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients aged 19-80 years
* Clinical T1-2, N0, without distant metastasis on imaging
* If surgical treatment is required after ESD (endoscopic mucosal resection)\*
* If endoscopic lesion marking is required as determined by the attending physician
Exclusion Criteria:
* Patients diagnosed with distant metastases (M1)
* Severe hepatic or renal dysfunction (Child-Pugh Class C, eGFR \<39 mL/min/1.73 m2)
* Pregnant or lactating women
* High risk of intestinal obstruction or perforation
* Patients deemed inappropriate by the investigator (high-risk patients, such as patients with lung or heart disease, risk factors for bleeding, hepatitis virus infection, or other cancers)
* Patients with a history of hypersensitivity to the luminomarker drug or its components
* Patients who have experienced skin hypersensitivity to the dye
* Patients who do not wish to participate in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Distance between endoscopic lesion markings and lesion location markings using luminomarkers for accuracy of tattooing