EGFR Mutation Targeting Molecular Probe for PET Imaging

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT06641674
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

In this project, investigators plan to develop a F-18 labeled molecular probe in order to detect the EGFR mutation tumor lessions in patients to identify patients benefiting fromTKIs treatment, and evaluate its efficacy in detecting EGFR Del 19 mutant lung cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15
• Study Start: 2024-11-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male and female, aged 18-75 years old (including 18 and 75 years old), ECOG score 0 or 1.
2. Patients could understand and sign the informed consent form voluntarily with good compliance.
3. Patients with histologically or cytologically or clinically confirmed lung cancer with measurable disease.
4. Women had to be using an effective contraceptive method (effective contraceptive means sterilisation, intrauterine hormonal devices, condoms, contraceptives/pills, sexual abstinence, or partner's removal of the vas deferens) during the study and for 6 months after the study. Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period.
5. Predicted survival greater than 3 months;

Exclusion Criteria

1. Severe hepatic or renal dysfunction;
2. Pregnant or nursing;
3. Known allergy to the investigational drug or its excipients in study;
4. Unable to comply with the PET/CT imaging procedures;
5. Claustrophobia or other psychiatric disorders;
6. Other conditions deemed unsuitable for participation in the trial;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Standard Uptake Value Value	1 year	The standardized uptake value (SUV) of 18F-LF13 in EGFR mutation lesion measured by PET/CT

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China