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

August 21, 2026 updated by: Hua Zhu, Peking University Cancer Hospital & Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-NC-BCH
Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-NC-BCH PET/CT scan.
Drug: 18F-FDG
All study participants will undergo one 18F-FDG PET/CT scan.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance
Time Frame: 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).
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Hua Zhu, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

June 23, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022KT96

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe