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Recruiting NCT07144085

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

Phase I Interventional Tumor Metastatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 68Ga-FXX489, Positron Emission Tomography (PET) imaging, Gallium-68 labelled (68Ga-) FAP-2286.
Who it may be relevant to
Registry conditions: Tumor, Metastatic Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Count of participants with treatment-emergent adverse events [Time frame: Up to 3 days]
  • Proportion of radiation-absorbed doses of radiolabeled FAP-2286. [Time frame: Up to 3 days]
  • Standardized Uptake Values (SUVs) [Time frame: Up to 3 days]
  • Tumor-to-background (TBR) Ratio [Time frame: Up to 3 days]
  • Proportion of positive lesions on FXX489(NNS306) PET [Time frame: Up to 3 days]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • The First Hospital of China Medical University — Shenyang

Identifiers

NCT: NCT07144085 · [2025]670

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗