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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05436093
• Other study ID #: 2022KT96
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Peking University Cancer Hospital & Institute
• Contact: Hua Zhu
• Phone: 010-88196495
• Email: zhuhuabch[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
China	Beijing cancer hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value(SUV)	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.	2 years