CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05436093

Enrollment

Registered

2022-06-28

Start date

2022-06-23

Completion date

2027-12-01

Last updated

2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

Brief summary

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.

Interventions

DRUG18F-FDG

All study participants will undergo one 18F-FDG PET/CT scan.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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; * 5\. Suffering from claustrophobia or other mental diseases; * 6\. Any other situation that researchers think it is not suitable to participate in the experiment.

Design outcomes

Primary

Measure	Time frame	Description
Standardized Uptake Value (SUV) of 68Ga-NC-BCH	2 years	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.

Secondary

Measure	Time frame	Description
Diagnostic performance	4 years	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).

Countries

China

Contacts

CONTACTHua Zhu

zhuhuabch@pku.edu.cn010-88196495

PRINCIPAL_INVESTIGATORHua Zhu

Peking University Cancer Hospital & Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026