NCT07144085

Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yi Tian · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A new radiotracer, 68Ga-FXX489 (NNS309), has been developed for tracking fibroblast activation protein (FAP) and visualizing the tumor stroma. The purpose of the study is to explore the diagnostic value of 68Ga-FXX489 (NNS309) PET/CT imaging in oncological diseases, to assess its safety, imaging characteristics, and biodistribution after administration.

Detailed description

Initially the investigator(s) will focus on imaging pancreatic cancer, lung cancer, breast cancer, gastric cancer, colorectal cancer. STUDY AIMS 1. Determine the dosimetry for gallium-68 labelled 68Ga- FXX489(NNS309). 2. Evaluate the uptake and retention of radiotracer in a variety of solid tumors with 68Ga- FXX489(NNS309). 3. Evaluate the ability of FAP-2286 to detect metastatic disease. PRIMARY OBJECTIVES 1.Safety of 68Ga- FXX489(NNS309). 2.determine the organ dosimetry of 68Ga- FXX489(NNS309). 3.To assess the feasibility of detecting tumor uptake using FXX489(NNS309). 4.To determine the feasibility of detecting metastatic disease using FXX489(NNS309). EXPLORATORY OBJECTIVES 1. Determine impact of administered dose of FXX489(NNS309) on image quality. 2. Compare the feasibility of detecting tumor uptake using FXX489(NNS309) and FAP-2286 . A repeat radiolabeled FXX489(NNS309) PET may be obtained after initiation of subsequent treatment in order to evaluate changes in PET uptake due to treatment effect. Patients will be followed for up to 3 days after the injection of radiolabeled ligand for evaluation of adverse events.

Conditions

• Tumor
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	68Ga-FXX489	The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging.
PROCEDURE	Positron Emission Tomography (PET) imaging	Participants will be scanned for approximately 30 to 45 minutes.
DRUG	Gallium-68 labelled (68Ga-) FAP-2286	The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging.

Timeline

• Start date: 2025-09-11
• Primary completion: 2027-07-30
• Completion: 2027-07-30
• First posted: 2025-08-27
• Last updated: 2026-04-03

Locations

1 site across 1 country: China