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

• Sponsor: Peking University Cancer Hospital & Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05436093
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11.3
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: 18F-FDG	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors
• Actual Study Start Date: Jun 23, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 68Ga-ACN376 Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-ACN376 PET/CT scan.	Drug: 18F-FDG; All study participants will undergo one 18F-FDG PET/CT scan.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Aged >18 years old; ECOG 0 or 1;
• 1. Patients with solid tumors;
• 1. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
• 1. life expectancy >=12 weeks.

Exclusion Criteria:

• 1. Significant hepatic or renal dysfunction;
• 1. Is pregnant or ready to pregnant;
• 1. Cannot keep their states for half an hour;
• 1. Refusal to join the clinical study;
• 1. Suffering from claustrophobia or other mental diseases;
• 1. Any other situation that researchers think it is not suitable to participate in the experiment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing cancer hospital	Beijing	Beijing	China	100142

Sponsors and Collaborators

• Peking University Cancer Hospital & Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hua Zhu, Associate Professor, Peking University Cancer Hospital & Institute
• ClinicalTrials.gov Identifier: NCT05436093
• Other Study ID Numbers: 2022KT96
• First Posted: Jun 28, 2022
• Last Update Posted: Jun 28, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Fluorodeoxyglucose F18

Study Results

No Results Posted as of Jun 28, 2022