Not yet recruiting NCT06641674
EGFR Mutation Targeting Molecular Probe for PET Imaging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-LF13.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development and Clinical Translation of EGFR Mutation Targeting PET Probe
Overview
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.
Interventions
- Drug 18F-LF13
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.
Primary outcome measures
- Standard Uptake Value Value [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion criteria
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT06641674 · 2024YJZ02