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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-07-31

Brief Summary

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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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Detailed Description

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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

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Tumor Metastatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tumor population

PET imaging will begin 30 +/-10 minutes, 60 +/-15 minutes and 120 +/-20 minutes after injection of 68Ga-FXX489 or 68Ga-FAP-2286 or 18F-FDG.

Group Type EXPERIMENTAL

68Ga-FXX489

Intervention Type 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

Intervention Type PROCEDURE

Participants will be scanned for approximately 30 to 45 minutes.

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

Intervention Type DRUG

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

Interventions

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68Ga-FXX489

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

Intervention Type DRUG

Positron Emission Tomography (PET) imaging

Participants will be scanned for approximately 30 to 45 minutes.

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients with a high suspicion of oncological diseases.
2. 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

1. Failure to sign the informed consent form.
2. Severe visual or auditory impairment, cognitive disorders, or patients with claustrophobia who cannot communicate effectively.
3. Severe cardiac dysfunction, cardiac function class III-IV.
4. Renal failure (serum creatinine level \> 1.2 mg/dl).
5. Allergy to alcohol.
6. 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.
7. Known pregnancy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No