Cancer
Conditions
Keywords
PET imaging, EGFR mutation
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.
Interventions
DRUG18F-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.
Sponsors
Peking University Cancer Hospital & Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Uptake Value Value | 1 year | The standardized uptake value (SUV) of 18F-LF13 in EGFR mutation lesion measured by PET/CT |
Countries
China
Contacts
Primary ContactZhi Yang
Backup ContactHua Zhu
Outcome results
None listed