Colorectal CancerTattooingNCT07380867
Confirming the Accuracy of Endoscopic Marking Using a New Marker, a Novel Luminomarker, in Lesion Marking Before Colorectal Cancer Surgery.
A study testing LuminoMark inj. 0.2mL in people with Colorectal Cancer and Endoscopic Tattoo of Suspected Colon Cancer, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Colorectal Cancer, Endoscopic Tattoo of Suspected Colon Cancer, Indocyanine Green (ICG)
- What is being tested?
- LuminoMark inj. 0.2mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul St.Mary's hospital, the Catholic university of Korea
Seoul, Seoul, 06591
About this study
Official title: Localization of Preoperative Endoscopic Tattooing Using Indocyanine Green(ICG)-Hyaluronic Acid Mixture (Luminomark) for Colorectal Cancer Surgery
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.
Read the detailed description
The recently developed indocyanine green (ICG)-hyaluronic acid mixture (LuminoMark™, Hanlim Pharm Co., Seoul, Republic of Korea) is a surgical marker combining indocyanine green with macroaggregated albumin (MAA). Its non-diffusing properties allow for precise lesion targeting. It addresses unmet needs of existing surgical markers, such as skin pigmentation and surgical site contamination. It effectively adsorbs onto cancerous lesions, enabling precise lesion location. Real-time tracking of the pigment allows for clear identification of the lesion's extent of removal, enhancing convenience and usability during surgery. It has already demonstrated superiority over existing labeling methods in a phase 3 clinical trial for breast lesions, receiving approval from the Ministry of Food and Drug Safety. Clinical trials are underway for various cancer types, including gastric and colon cancer, but it remains an over-approved drug.
Therefore, this study aimed to determine the accuracy of endoscopic labeling using a novel luminomarker for preoperative colon cancer lesion marking.
- Being tested
- LuminoMark inj. 0.2mL
- Keywords
- endoscopic tattooing, colorectal cancer, indocyanine green, LuminoMark
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuminoMark inj. 0.2mLDrug
- Endoscopic tattooing with Luminomark on submucosal layer of bowel
- Location of injection : total 4 sites
- Left lateral side of the tumor
- Right lateral side of the tumor
- opposite side of the tumor
- distal side of the tumor
- Dosage of injection: -at least 0.5cc per a site, total 2ml
| Study group | Role | What they receive |
|---|---|---|
| Luminomarker injection | Experimental | Through endoscopy, Luminomarker injection on submucosal layer. Location of injection : total 4 sites around tumor
1. Left lateral side of tumor
2. Right lateral side of tumor
3. opposite of tumor (180 degree)
4. distal part of 2cm from the tumor
dosage of injection : at least 0.5cc per a site , total 2cc Receives: Drug: LuminoMark inj. 0.2mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between endoscopic lesion markings and lesion location markings using luminomarkers for accuracy of tattooing
- Mix 1 vial (2 ml) of Indocyanine Green (ICG) + Hyaluronic Acid Mixture (Luminomarker™) with 1 vial (2 ml) of the attached solvent. Shake gently to dissolve thoroughly.
- After performing an endoscopy to identify the lesion, attach the syringe to the endoscopic injector and mark at least three locations with at least 0.2 cc each.
- After general anesthesia, insert a trocar for laparoscopic or robotic surgery and insert the laparoscopic equipment. Use a Laparoscopic near-intrared (NIR) camera to confirm the lesion marking.
After marking with a surgical hemoclip, take a photograph and mark with a hemoclipping. A tumor is confirmed at the ICG-marked location in the obtained specimen.
Measured: Perioperative/Periprocedural
Secondary outcomes (1)
post-procedure related complication
- Check for fever above 38°C (100°F) and abdominal pain before and after the procedure, and any abnormal findings such as free air on a simple X-ray.
- Check for allergic reactions to medications.
- Check for any postoperative complications and postoperative pathology results.
Measured: through postoperative 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start22 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- * 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanlim Pharm. Co., Ltd.
- Responsible party
- Principal investigator, In Kyeong Kim, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380867
- Sponsor's protocol ID
- KC25MASI0456
- Acronym
- Tattooing
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localization of Preoperative Endoscopic Tattooing Using Indocyanine Green(ICG)-Hyaluronic Acid Mixture (Luminomark) for Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT07380867
- Acronym / sponsor ID
- Tattooing / KC25MASI0456
- Keywords
- endoscopic tattooing, colorectal cancer, indocyanine green, LuminoMark
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Hanlim Pharm. Co., Ltd.
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The recently developed indocyanine green (ICG)-hyaluronic acid mixture (LuminoMark™, Hanlim Pharm Co., Seoul, Republic of Korea) is a surgical marker combining indocyanine green with macroaggregated albumin (MAA). Its non-diffusing properties allow for precise lesion targeting. It addresses unmet needs of existing surgical markers, such as skin pigmentation and surgical site contamination. It effectively adsorbs onto cancerous lesions, enabling precise lesion location. Real-time tracking of the pigment allows for clear identification of the lesion's extent of removal, enhancing convenience and usability during surgery. It has already demonstrated superiority over existing labeling methods in a phase 3 clinical trial for breast lesions, receiving approval from the Ministry of Food and Drug Safety. Clinical trials are underway for various cancer types, including gastric and colon cancer, but it remains an over-approved drug.
Therefore, this study aimed to determine the accuracy of endoscopic labeling using a novel luminomarker for preoperative colon cancer lesion marking.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * 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
| Arm | Type | Receives |
|---|---|---|
| Luminomarker injection | Experimental | Drug: LuminoMark inj. 0.2mLThrough endoscopy, Luminomarker injection on submucosal layer. Location of injection : total 4 sites around tumor 1. Left lateral side of tumor 2. Right lateral side of tumor 3. opposite of tumor (180 degree) 4. distal part of 2cm from the tumor dosage of injection : at least 0.5cc per a site , total 2cc |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuminoMark inj. 0.2mL* Endoscopic tattooing with Luminomark on submucosal layer of bowel * Location of injection : total 4 sites 1. Left lateral side of the tumor 2. Right lateral side of the tumor 3. opposite side of the tumor 4. distal side of the tumor * Dosage of injection: -at least 0.5cc per a site, total 2ml | Drug | Luminomarker injection |
Primary outcome
Distance between endoscopic lesion markings and lesion location markings using luminomarkers for accuracy of tattooing
Time frame: Perioperative/Periprocedural
* Mix 1 vial (2 ml) of Indocyanine Green (ICG) + Hyaluronic Acid Mixture (Luminomarker™) with 1 vial (2 ml) of the attached solvent. Shake gently to dissolve thoroughly. * After performing an endoscopy to identify the lesion, attach the syringe to the endoscopic injector and mark at least three locations with at least 0.2 cc each. * After general anesthesia, insert a trocar for laparoscopic or robotic surgery and insert the laparoscopic equipment. Use a Laparoscopic near-intrared (NIR) camera to confirm the lesion marking. After marking with a surgical hemoclip, take a photograph and mark with a hemoclipping. A tumor is confirmed at the ICG-marked location in the obtained specimen.
1 secondary outcome
post-procedure related complication
Time frame: through postoperative 4 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LuminoMark inj. 0.2mL in people with Colorectal Cancer and Endoscopic Tattoo of Suspected Colon Cancer, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between endoscopic lesion markings and lesion location markings using luminomarkers for accuracy of tattooing (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.