RecruitingPhase 1NCT07144085

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


Sponsor

Yi Tian

Enrollment

30 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • Patients with a high suspicion of oncological diseases.
  • Age: 18-80 years, no gender restriction, able to express themselves independently, and willing to participate in this study with a signed informed consent form.

Exclusion Criteria7

  • Failure to sign the informed consent form.
  • Severe visual or auditory impairment, cognitive disorders, or patients with claustrophobia who cannot communicate effectively.
  • Severe cardiac dysfunction, cardiac function class III-IV.
  • Renal failure (serum creatinine level \> 1.2 mg/dl).
  • Allergy to alcohol.
  • Use of drugs within 1 week prior to the examination that can cause a disulfiram-like reaction with alcohol, such as penicillins, cephalosporins, or cefotetan.
  • Known pregnancy.

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Interventions

DRUG68Ga-FXX489

The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging.

PROCEDUREPositron Emission Tomography (PET) imaging

Participants will be scanned for approximately 30 to 45 minutes.

DRUGGallium-68 labelled (68Ga-) FAP-2286

The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging.


Locations(1)

The First Hospital of China Medical University

Shenyang, Liaoning, China

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NCT07144085


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