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NCT Number: NCT07144085

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

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.

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Key information

Conditions

Tumor Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location status: Recruiting

Location contact

Xuena Li

CONTACT

[email protected]

0086-18040099351

About this study

Initially the investigator(s) will focus on imaging pancreatic cancer, lung cancer, breast cancer, gastric cancer, colorectal cancer.

STUDY AIMS

  • Determine the dosimetry for gallium-68 labelled 68Ga- FXX489(NNS309).
  • Evaluate the uptake and retention of radiotracer in a variety of solid tumors with 68Ga- FXX489(NNS309).
  • 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

  • Determine impact of administered dose of FXX489(NNS309) on image quality.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-FXX489

Drug

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

Positron Emission Tomography (PET) imaging

Procedure

Participants will be scanned for approximately 30 to 45 minutes.

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

Drug

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

Primary outcomes

  1. Count of participants with treatment-emergent adverse events

    Time frame: Up to 3 days

    The frequency and severity of treatment emergent adverse events following FXX489(NNS306) injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

  2. Proportion of radiation-absorbed doses of radiolabeled FAP-2286.

    Time frame: Up to 3 days

    Volumes of interest of 68Ga- will be drawn around regions identified on the scans, including the liver, spleen, kidneys, urinary bladder, the central sacrum (for hematopoietic marrow) and whole body. Data will be fitted using the Simulation, Analysis, and Modeling Software II (SAAM II) software. Time integrals of activity will be entered into the Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM) software, using the reference adult model. The results from all patients enrolled will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs

  3. Standardized Uptake Values (SUVs)

    Time frame: Up to 3 days

    The maximum Standardized Uptake Value (SUVmax) will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity.

  4. Tumor-to-background (TBR) Ratio

    Time frame: Up to 3 days

    TBR ratios will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity. The median and range of the measured TBRs will be reported across all RECIST measurable lesions as a table broken down by location (organ metastases, nodal metastases and bone metastases).

  5. Proportion of positive lesions on FXX489(NNS306) PET

    Time frame: Up to 3 days

    Conventional imaging will be reviewed in conjunction with the FXX489(NNS306) PET images. Lesions will be characterized as positive on FXX489(NNS306) PET if uptake is greater than 1.5 times higher than mediastinal blood pool and uptake cannot be attributed to physiologic or inflammatory reasons. Conventional imaging will be interpreted as positive by each lesion if the short axis dimension of lymph nodes is greater than 1 centimeter (cm), and organ metastases measure greater than 1 cm in long axis. The gold standard will be the combination of conventional imaging and FXX489(NNS306) PET in combination with clinical follow-up and histopathology (if available). The number of lesions detected by each modality will be compared and sensitivity will be computed. Since this is a proof-of-concept study, it is not powered for the test of agreement. Nevertheless, the agreement will be tested using McNemar's test.

Study contacts

Contact information is provided by the study sponsor or research team.

Xuena Li

CONTACT

[email protected]

0086-18040099351

Sponsors and collaborators

Lead sponsor

Yi Tian

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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