CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute
About this trial
The objective of the study is to construct a noninvasive approach 68Ga-NC-BCH PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Aged >18 years old; ECOG 0 or 1;
2. Patients with solid tumors;
3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
4. life expectancy >=12 weeks.
Disqualifiers
1. Significant hepatic or renal dysfunction;
2. Is pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refusal to join the clinical study;
Trial design
Design model
Single group
Treatments tested in this trial
18F-FDG
DrugAll study participants will undergo one 18F-FDG PET/CT scan.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: 68Ga-NC-BCHExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Standardized Uptake Value (SUV) of 68Ga-NC-BCH
SUV is a semiquantitative index commonly used in PET to quantify tissue metabolic activity, calculated as the ratio of the radioactivity concentration in the tissue of interest to the injected dose normalized by body weight. Bio-distribution of the tracer will be assessed by measuring the Standardized Uptake Value (SUV) in normal organs (e.g., liver, spleen, kidney) via PET/CT imaging at specified time points post-injection.
Time frame
2 yearsSecondary outcomes
1
Diagnostic performance
To evaluate the diagnostic permormance of 68Ga-NC-BCH PET/CT in identifying CLDN18.2-positive lesions, using immunohistochemistry (IHC)as the reference standard. The diagnostic performance will be assessed by receiver operating characteristic (ROC) curve analysis, with calculation of the area under the curve (AUC).
Time frame
4 yearsSponsors and contacts
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Source ClinicalTrials.gov