EGFR Mutation Targeting Molecular Probe for PET Imaging

NCT06641674 | Not Yet Recruiting

• 1 other identifier: 2024YJZ02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

PET imaging; EGFR mutation

Outcome Measures

Primary Outcomes (1)

• Standard Uptake Value Value

  The standardized uptake value (SUV) of 18F-LF13 in EGFR mutation lesion measured by PET/CT

  1 year

Interventions

18F-LF13 DRUG

18F-LF13 PET/CT: after intravenous injection of 1.85 - 3.7 MBq/kg body weight of quality-controlled 18F-LF13, a Siemens Biograph PET/CT scan will be applied within 0.5 h, and the scan range will be from the top of the head to 1/3 of the upper thigh, 2 h to 4 h delayed scanning can be added if necessary.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Lung cancer patients or lung cancer patients treated with TKIs

You may qualify if:

• Male and female, aged 18-75 years old (including 18 and 75 years old), ECOG score 0 or 1.
• Patients could understand and sign the informed consent form voluntarily with good compliance.
• Patients with histologically or cytologically or clinically confirmed lung cancer with measurable disease.
• 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.
• Predicted survival greater than 3 months;

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Zhi Yang

CONTACT

010-88196196; pekyz@163.com

Hua Zhu

CONTACT

zhuhuabch@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: November 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)