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NCT Number: NCT05436093

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

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.

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Key information

Conditions

Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing cancer hospital

Beijing, Beijing Municipality, 100142, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F-FDG

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 28, 2022
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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