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NCT04593615: CLASS-11
Indocyanine Green Tracer Using in Laparoscopic Radical Gastrectomy for Locally Advanced Gastric Cancer
NA trial testing ICG near-infrared imaging in Gastric Cancer in 1,070 participants. Participants enrolled and being followed up; not accepting new ones.
17 August 2026
Quick facts
| Lead sponsor | Fujian Medical University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,070 |
| Start date | 10 November 2020 |
| Primary completion | 17 August 2026 |
| Estimated completion | 17 August 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- ICG near-infrared imaging
Conditions studied
- Gastric Cancer — all drugs for Gastric Cancer →
- Surgery — all drugs for Surgery →
Sponsor
Fujian Medical University
Who can join
Adults 18 to 75, any sex, with Gastric Cancer or Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with locally advanced gastric adenocarcinoma (CT2-4a N0/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic D2 lymph node dissection for gastric cancer by comparing injection ICG group and non-injection ICG group.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Indocyanine green fluorescence imaging-guided versus conventional laparoscopic lymphadenectomy for gastric cancer: long-term outcomes of a phase 3 randomised clinical trial.
Chen QY, Zhong Q, Liu ZY, Li P, et al · · 2023 · cited 46× · PMID 37973806 · DOI 10.1038/s41467-023-42712-6 -
Potential Probes for Targeted Intraoperative Fluorescence Imaging in Gastric Cancer.
Martinelli S, Fortuna L, Coratti F, Passagnoli F, et al · · 2024 · cited 4× · PMID 39766041 · DOI 10.3390/cancers16244141 -
Safety and efficacy of indocyanine green-guided laparoscopic lymphadenectomy for locally advanced gastric cancer: The CLASS-11 clinical trials.
Zheng CH, Chen YB, Yu WB, Cai LS, et al · · 2025 · cited 3× · PMID 40398388 · DOI 10.1016/j.xcrm.2025.102136 -
Comparison of a submucosal and subserosal approach in ICG-guided laparoscopic lymphadenectomy in gastric cancer patients: long-term outcomes of a phase 3 randomized clinical trial.
Zhong Q, Shang-Guan ZX, Liu ZY, Wu D, et al · · 2025 · cited 2× · PMID 39903562 · DOI 10.1097/js9.0000000000002271 -
Long-term oncological outcomes of indocyanine green fluorescence imaging-guided laparoscopic lymphadenectomy for gastric cancer: 5-year outcomes from the FUGES-012 randomized clinical trial.
Zhong Q, Wu D, Liu ZY, Shang-Guan ZX, et al · · 2025 · cited 1× · PMID 40859341 · DOI 10.1186/s12916-025-04334-1 -
Current clinical trials on gastric cancer surgery in China.
Zhang S, Hu RH, Cui XM, Song C, et al · · 2024 · PMID 39554743 · DOI 10.4251/wjgo.v16.i11.4369
Verify or expand the search:
- PubMed search for NCT04593615
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Fujian Medical University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04593615 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fujian Medical University
- Last refreshed: 30 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04593615.
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