Glow-in-the-Dark dye could help surgeons spot hidden cancer
NCT ID NCT07538648
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing an injectable dye called NC527-X that may make tumors glow during surgery, helping surgeons see exactly where the cancer is. The study will enroll 400 adults with solid tumors who are already scheduled for surgery. Participants receive one of four different doses of the dye before their operation, and researchers measure how well the dye highlights the tumor compared to healthy tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NC527-X (an injectable imaging agent)
- What this could lead to
- If successful, this could give surgeons a real-time way to see tumor edges during surgery, potentially leading to more complete tumor removal.
- What could go wrong
- This is an early Phase 1 trial with small dose groups, so it is mainly testing safety and the right dose. The imaging agent may not work well for all tumor types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: 1. 1\. Voluntarily sign a written informed consent form; 2. 2\. Male and female individuals aged 18 years or above; 3. 3\. Patients with solid tumors that have been diagnosed by imaging tests or confirmed by pathology and who are scheduled for surgical removal; 4. 4\. The ECOG score ranges from 0 to 1; 5. 5\. During the trial period, the subjects used effective contraceptive methods and continued to use contraception for another 3 months after the medication was completed. 6. 6\. Be able to understand the procedures and methods of this study, and be willing to strictly follow the clinical trial protocol and complete this trial. Exclusion criteria: 1. 1\. Has a history of allergic reactions to similar products, contrast agents, or fluorescent lamps, or is known to be allergic to the study drug or any other components. 2. 2\. 28 days prior to the first administration, the subject had received a similar drug (such as indocyanine green for injection); 3. 3\. Within one month prior to the first administration, participants were enrolled in another clinical study (including observational or non-interventional clinical studies); 4. 4\. Within 28 days prior to the first administration, had received a live attenuated vaccine; 5. 5\. Within one month prior to the first administration, had undergone major surgical procedures (as defined by the investigators); 6. 6\. The subjects had previously undergone allogeneic stem cell or solid organ transplantation; 7. 7\. Within 28 days prior to the first administration, there were adverse reactions caused by previous treatments that had not recovered to grade 1 or below according to CTCAE 5.0 criteria (pigmentation, hair loss; adverse reactions that the investigator deemed safe can be included); 8. 8\. The laboratory test results during the screening period indicated that the subjects did not have good organ function: a. Hematology (Blood transfusion within 14 days before the screening laboratory tests and treatment with blood components or granulocyte colony-stimulating factor need to be excluded) i. Absolute neutrophil count \< 1.5 × 109/L (1,500/mm3); ii. Platelet count \< 75 × 109/L; iii. Hemoglobin \< 9.0 g/dL; b. Liver i. Serum total bilirubin (TBil) \> 1.5 × ULN; for subjects with liver metastasis or those with evidence of or suspected Gilbert's disease, TBil \> 3 × ULN; ii. AST and ALT \> 2.5 × ULN, for subjects with liver metastasis, AST and ALT \> 5 × ULN; c. Kidney: Serum creatinine \> 1.5 × ULN; or glomerular filtration rate estimated according to the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI formula, see Appendix 2) \< 60 mL/(min \* 1.73m2); d. Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) \> 1.5 × ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected range for anticoagulant treatment at the time of screening); 9. 9\. Patients with primary central nervous system tumors or those with symptomatic central nervous system metastases (meningeal metastases, regardless of whether they are symptomatic or not, must be excluded); 10. 10\. Within 6 months prior to the first administration of the drug, the following cardiovascular diseases occurred: symptomatic heart failure with a New York Heart Association (NYHA) classification of 2 or above (see Appendix 3), left ventricular ejection fraction (LVEF) \< 50%, unstable arrhythmia or unstable angina pectoris, myocardial infarction requiring treatment, pulmonary embolism, uncontrolled hypertension (this protocol defines uncontrolled hypertension as although the optimal antihypertensive treatment is adopted, but after treatment, systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg, and the investigator assesses it to have clinical significance). Note: Three 12-lead electrocardiograms indicating QTc interval prolongation \> 450 milliseconds (ms) (for males) or 470 ms (for females) must be excluded; For atrial fibrillation or paroxysmal supraventricular tachycardia that requires treatment but is assessed by the investigator to be stable, it can be considered for inclusion. 11. 11\. Within 4 weeks prior to the first administration of the drug, there was a history of severe infection or an active infection occurred within 2 weeks. 12. 12\. The following disease-infected individuals are present: Human Immunodeficiency Virus (HIV) infection; Active hepatitis B virus carriers \[Hepatitis B Surface Antigen (HBsAg) positive, and hepatitis B virus DNA (HBV-DNA) test result \> 200 IU/mL or 103 copies/mL\]; Hepatitis C virus carriers \[HCV antibody and viral RNA (HCV-RNA) test results are positive\]; Treponema pallidum antibody positive and RPR positive individuals; 13. 13\. Female subjects who have tested positive for pregnancy during the screening period, are currently breastfeeding, or plan to become pregnant or give birth during the course of this trial; Male subjects whose spouses have a pregnancy plan within the last 3 months. 14. 14\. Any other diseases, medical conditions or abnormalities, metabolic disorders, physical examination results, clinical laboratory test results that prohibit the use of the study drug, may affect the interpretation of the results, or may place the subjects at a high risk of treatment complications, or according to the investigator's judgment, are not suitable for using the study drug.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhejiang Cancer Hospital
RECRUITINGHangzhou, Zhejiang, 310000, China
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