EGFR Mutation Targeting Molecular Probe for PET Imaging (EGFR-PET)

Development and Clinical Translation of EGFR Mutation Targeting PET Probe

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Drug: 18F-LF13

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Zhi Yang; Phone Number: 010-88196196; Email: pekyz@163.com
• Study Contact Backup: Name: Hua Zhu; Email: zhuhuabch@pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
      • Contact: Hua Zhu; Phone Number: 010-88196495; Email: zhuhuaBCH@pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Lung cancer patients or lung cancer patients treated with TKIs

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: PET imaging; EGFR mutation
• Other Study ID Numbers: 2024YJZ02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No