Diagnostic Accuracy of Folate-Targeted NIR-II Carbon Dots for Ex Vivo HCC Detection

NCT ID: NCT07295340

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-10-01

Brief Summary

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This prospective, single-center observational study evaluates the diagnostic accuracy of a novel Folate-targeted Near-Infrared II Carbon Dot (FA-CDots) probe for the ex vivo assessment of Hepatocellular Carcinoma (HCC). Following standard radical hepatectomy, resected liver specimens will be incubated with the FA-CDots probe and imaged using a NIR-II fluorescence system. The study aims to determine the feasibility and accuracy of this technology in identifying tumor margins and micro-lesions by comparing the fluorescence imaging results with standard histopathological examination.

Detailed Description

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Conditions

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Liver Cancer

Keywords

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liver cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention group

Patients undergoing standard curative hepatectomy for HCC. Their resected tumor specimens will be used for ex vivo fluorescence imaging analysis.

Ex Vivo FA-CDots Staining

Intervention Type DIAGNOSTIC_TEST

The resected liver specimens are incubated with Folate-targeted Near-Infrared II Carbon Dots (FA-CDots) and imaged using a NIR-II fluorescence imaging system to identify tumor margins and micro-lesions. The results are compared with standard histopathology.

Interventions

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Ex Vivo FA-CDots Staining

The resected liver specimens are incubated with Folate-targeted Near-Infrared II Carbon Dots (FA-CDots) and imaged using a NIR-II fluorescence imaging system to identify tumor margins and micro-lesions. The results are compared with standard histopathology.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Primary diagnosis of Hepatocellular Carcinoma (HCC) confirmed clinically or by preoperative biopsy.
2. Scheduled for radical hepatectomy.
3. Preoperative imaging (CT/MRI) suggests indistinct tumor boundaries, infiltrative growth, or proximity to major vessels (expected margin \< 1cm).
4. Liver function classified as Child-Pugh Grade A.
5. ASA Physical Status classification I-III.
6. Participant or legal guardian willing to sign informed consent for the use of ex vivo tissues.

Exclusion Criteria

1. Concomitant other malignant tumors.
2. Severe dysfunction of heart, lung, kidney, or brain unable to tolerate surgery.
3. Recurrent HCC.
4. Preoperative evidence of extrahepatic metastasis or major vascular invasion.
5. Received preoperative anti-tumor therapy.
6. Pregnant or lactating women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiwei Huang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiwei Huang Professor

Role: CONTACT

Phone: 18980606725

Email: [email protected]

Facility Contacts

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Jiwei Huang Professor

Role: primary

Other Identifiers

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JHuang20234

Identifier Type: -

Identifier Source: org_study_id