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

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT07144085 est conçu pour étudier le diagnostic de Tumeur, Cancer métastatique. Il s'agit d'un essai interventionnel en Phase I. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 septembre 2025, avec un objectif de 80 participants. Dirigé par Yi Tian, l'essai devrait être terminé d'ici le 1 juillet 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 27 août 2025.
Résumé succinct
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.
Description détaillée
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.

Titre officiel

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

Conditions
TumeurCancer métastatique
Autres identifiants de l'essai
  • [2025]670
Numéro NCT
NCT07144085
Date de début (réel)
2025-09
Dernière mise à jour publiée
2025-08-27
Date de fin (estimée)
2027-07
Inscription (estimée)
80
Type d'essai
Interventionnel
PHASE
Phase I
Statut
Pas encore en recrutement
Objectif principal
Diagnostic
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalTumor 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.
68Ga-FXX489
The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging.
Positron Emission Tomography (PET) Imaging
Participants will be scanned for approximately 30 to 45 minutes.
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.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Count of participants with treatment-emergent adverse events
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
Up to 3 days
Proportion of radiation-absorbed doses of radiolabeled FAP-2286.
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
Up to 3 days
Standardized Uptake Values (SUVs)
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.
Up to 3 days
Tumor-to-background (TBR) Ratio
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).
Up to 3 days
Proportion of positive lesions on FXX489(NNS306) PET
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.
Up to 3 days
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  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.

  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.
Yi Tian logoYi Tian
Partie responsable de l'essai
Yi Tian, Promoteur-Investigateur, The Master's Degree Candidate of the Department of Nuclear Medicine, The First Affiliated Hospital of China Medical University, First Hospital of China Medical University
Contact central de l'essai
Contact: Xuena Li, 0086-18040099351, [email protected]
1 Centres de l'essai dans 1 pays

Liaoning

The First Hospital of China Medical University, Shenyang, Liaoning, 110001, China
Xuena Li, Contact, 0086-18040099351, [email protected]