Last reviewed · How we verify
NCT07510321
FL-261 Imaging for Cancer Diagnosis and Staging
trial testing [68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging in Non-Small Cell Lung Cancer in 12 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 12 |
| Start date | 27 November 2025 |
| Primary completion | 30 June 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- [68Ga]Ga-FL-261 PET Imaging / [111In]In-FL-261 SPECT Imaging
Conditions studied
- Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Head & Neck Cancer — all drugs for Head & Neck Cancer →
- Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Who can join
18 and older, any sex, with Non-Small Cell Lung Cancer or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
c-MET is a receptor tyrosine kinase overexpressed in multiple malignancies and associated with tumor progression, therapeutic resistance, and poor prognosis, while showing limited expression in normal tissues, making it an attractive imaging and therapeutic target. Current assessment relies on invasive biopsy and is limited by tumor heterogeneity and sampling bias. FL-261 is a novel c-MET-targeting ligand with high affinity and specificity, favorable tumor uptake and retention, rapid background clearance, and good preclinical safety. It can be radiolabeled for both diagnostic imaging and potential theranostic applications. This first-in-human study will evaluate \[68Ga\]Ga-FL-261 PET or \[111In\]In-FL-261 SPECT imaging in patients with advanced malignancies, including non-small cell lung cancer, colorectal cancer, and head and neck cancer. The study aims to assess safety, biodistribution, and tumor-targeting capability, and to explore its diagnostic value by correlating imaging findings with histopathological c-MET expression.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07510321
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Non-Small Cell Lung Cancer
Currently open trials in the same condition.
- NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
- NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors · recruiting
- NCT07413757 — CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC · recruiting
- NCT07460999 — Singing Training vs Usual Care 6-18 Months After Surgical Resection for Non-small Cell Lung Cancer (NSCLC) · NA · recruiting
- NCT07479277 — Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC · NA · recruiting
Other Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials
Trials by the same sponsor.
- NCT07521124 — ABC Maintenance Therapy for AML · NA · not yet recruiting
- NCT07497243 — X-ray Assisted Diagnostic System · not yet recruiting
- NCT07520123 — Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatiti · NA · not yet recruiting
- NCT06970262 — FMT for Lung and Associated-organ Rescue Efficacy in ARDS Patients · NA · recruiting
- NCT07509424 — Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Lo · Phase 2 · not yet recruiting
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 NCT07510321 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Last refreshed: 3 April 2026
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/NCT07510321.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing