Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYi Tian
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-FXX489
DrugThe dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging.
Positron Emission Tomography (PET) imaging
Procedure/SurgeryParticipants will be scanned for approximately 30 to 45 minutes.
Gallium-68 labelled (68Ga-) FAP-2286
DrugThe dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Tumor populationExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Up to 3 days2
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
Time frame
Up to 3 days3
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.
Time frame
Up to 3 days4
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).
Time frame
Up to 3 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yi Tian
Lead sponsor
First Hospital of China Medical University
Sponsor institution
Source ClinicalTrials.gov