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

Not Applicable

Recruiting

• Conditions: Solid Tumor
• Interventions: Drug: 18F-FDG

• Registration Number: NCT05436093
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

The objective of the study is to construct a noninvasive approach 68Ga-ACN376 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-23
• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-ACN376	18F-FDG	Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-ACN376 PET/CT scan.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value（SUV）	2 years	SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （68Ga-ACN376） in solid tumor lesions by measuring SUV on PET/CT.

Trial Locations

Locations (1)

Beijing cancer hospital; 🇨🇳 Beijing, Beijing, China