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NCT Number: NCT06641674

EGFR Mutation Targeting Molecular Probe for PET Imaging

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Primary outcomes

  1. Standard Uptake Value Value

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Zhu

CONTACT

[email protected]

Zhi Yang

CONTACT

[email protected]

010-88196196

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

Development and Clinical Translation of EGFR Mutation Targeting PET Probe

Acronym: EGFR-PET

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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