Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this trial
Lung malignant tumors are a significant health threat with high incidence and mortality rates, and molecular imaging is crucial for early diagnosis, staging, prognosis evaluation, and therapeutic efficacy assessment. 18F-FDG PET imaging is widely used, but has limitations. CDH3 is a promising target for tumor-targeted imaging, as it is only expressed in cancerous epithelial cells. A new PET probe, 68Ga-TOI-1, targeting CDH3 has been developed with better affinity and selectivity than previous probes. Preclinical data support its safety and metabolic stability, and future research will explore its diagnostic and staging value in different types of lung tumors, providing a new and precise evaluation method for lung malignant tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, male or female, with an ECOG performance status of 0 or 1;
Availability of complete clinical and imaging data;
Life expectancy ≥ 12 weeks;
Hematology, liver and kidney function meeting the following criteria: Hematology: WBC ≥ 4.0 × 10⁹/L or neutrophils ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, Hb ≥ 90 g/L; PT or APTT ≤ 1.5 × ULN; Liver and kidney function: T-Bil ≤ 1.5 × ULN, ALT/AST ≤ 2.5 × ULN, ALP ≤ 2.5 × ULN; BUN ≤ 1.5 × ULN, SCr ≤ 1.5 × ULN;
Disqualifiers
Women who are planning pregnancy, pregnant, or breastfeeding;
History of other malignant tumors or prior receipt of other anti-tumor therapies;
Poor or missing PET scan image quality of the probe that fails to meet analysis standards;
Presence of claustrophobia or other mental illnesses;
Trial population
This single-center, prospective, single-arm study plans to enroll 30 patients with lung cancer receiving neoadjuvant immunochemotherapy and 50 patients with pulmonary nodules highly suspected of malignancy based on clinical diagnostic criteria who are scheduled to undergo wedge resection or anatomic lobectomy/sublobar resection.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PET/CT scans
Diagnostic testPET Dynamic Data: The tracer is administered based on the patient's body weight at approximately 0.06-0.12 mCi/kg. PET scanning is initiated simultaneously with tracer injection, followed by a flush with 10 ml of normal saline. The image acquisition matrix is 192 × 192. Reconstruction is performed using the OSEM algorithm with 4 iterations and 20 subsets, incorporating time-of-flight attenuation correction, scatter correction, and random correction. The total duration of PET dynamic data acquisition is 60 minutes. Processing of PET dynamic scan data: Dynamic PET images are divided into 2-minute intervals to obtain time-activity curves by extracting the radioactivity within regions of interest at different time points, reflecting tracer uptake and enabling calculation of the time to peak. Multi-modality imaging data are analyzed by radiologists with over 10 years of experience in diagnosing respiratory diseases.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: CDH3-targeted PET in lung malignant tumors1 intervention
Trial outcomes
Primary outcomes
1
The diagnostic sensitivity and specificity of 68Ga-TOI-1 PET/CT in the staging of lung malignant tumors.
The diagnostic performance of 68Ga-TOI-1 PET/CT and 18F-FDG PET/CT for initial staging will be evaluated and compared using histopathological findings or typical imaging features as reference standard.
Time frame
up to 6 weeksSecondary outcomes
1
Maximum Standardized Uptake Value [SUVmax] of Primary and Metastatic Lesions on 68Ga-TOI-1 PET/CT vs. 18F-FDG PET/CT
Comparison of maximum standardized uptake value (SUVmax) of primary and metastatic lesions between 68Ga-TOI-1 PET/CT and 18F-FDG PET/CT.
Time frame
up to 6 weeks2
Mean Standardized Uptake Value [SUVmean] of Primary and Metastatic Lesions on 68Ga-TOI-1 PET/CT vs. 18F-FDG PET/CT
Comparison of mean standardized uptake value (SUVmean) of primary and metastatic lesions between 68Ga-TOI-1 PET/CT and 18F-FDG PET/CT.
Time frame
up to 6 weeks3
Correlation between 68Ga-TOI-1 SUVmax and CDH3 H-score in Tumor Tissue
Evaluation of the correlation between maximum standardized uptake value (SUVmax) derived from 68Ga-TOI-1 PET/CT and CDH3 expression level measured by immunohistochemistry (IHC) as H-score (combining staining intensity and percentage of positive cells) in tumor tissue samples.
Time frame
up to 6 weeks4
Correlation between 68Ga-TOI-1 SUVmean and CDH3 H-score in Tumor Tissue
Evaluation of the correlation between mean standardized uptake value (SUVmean) derived from 68Ga-TOI-1 PET/CT and CDH3 expression level measured by immunohistochemistry (IHC) as H-score (combining staining intensity and percentage of positive cells) in tumor tissue samples.
Time frame
up to 6 weeksSponsors and contacts
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Source ClinicalTrials.gov