EGFR Molecular Classification In Vivo

Harbin Medical University

Status: Completed

Conditions: Molecular Imaging

Treatments: Radiation: 18F-IRS

Study type: Interventional

Funder types: Other

Identifiers

NCT03031522

14006

Details and patient eligibility

About

The investigators developed 18F-IRS as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-activating mutational status.

Full description

The goal of investigators were to evaluate the use of 18F-IRS as a novel PET/CT radiotracer to monitor EGFR-activating mutational status and identify EGFR-TKIs benefit NSCLC patients. the investigators want to evaluated the use of 18F-IRS in lung cancer imaging in adult NSCLC patients with different EGFR mutational status of primary and metastatic cancers.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Advanced NSCLC
• 18 years or older
• A life expectancy of at least 12 weeks
• Presence of a malignant lesion within the chest of at least 0.5 cm diameter as measured by computed tomography (CT)
• Written informed consent

Exclusion criteria

• Claustrophobia
• Pregnancy
• Metal implants in the thorax

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 6 patient groups

18F-IRS : EGFR+ Patients

Experimental group

Description:

Patients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study.

Treatment:

Radiation: 18F-IRS

18F-IRS :post-TKI EGFR+ Patients

Experimental group

Description:

Patients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study .

Treatment:

Radiation: 18F-IRS

18F-IRS:post-chemo EGFR+

Experimental group

Description:

18F-IRS:post-chemo EGFR+ Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study.

Treatment:

Radiation: 18F-IRS

18F-IRS:EGFR wild type

Experimental group

Description:

Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study.

Treatment:

Radiation: 18F-IRS

18F-IRS:post-chemo EGFR wild type

Experimental group

Description:

Patients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study.

Treatment:

Radiation: 18F-IRS

18F-IRS:unknown EGFR mutational status

Experimental group

Description:

Patients without the EGFR mutational status measurement results and did not receive any treatments were classified in this group

Treatment:

Radiation: 18F-IRS