EGFR Molecular Classification In Vivo

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

Detailed Description
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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.

Official Title
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Molecular Imaging to Identify EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients

Conditions
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Molecular Imaging

Intervention / Treatment
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* Radiation: 18F-IRS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-IRS : EGFR+ Patients<br>Patients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study. | Radiation: 18F-IRS<br>* According to experiment, 18F-IRS was non-toxic and stable in serum.<br>|
| Experimental: 18F-IRS :post-TKI EGFR+ Patients<br>Patients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study . | Radiation: 18F-IRS<br>* According to experiment, 18F-IRS was non-toxic and stable in serum.<br>|
| Experimental: 18F-IRS:post-chemo EGFR+<br>18F-IRS:post-chemo EGFR+ Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study. | Radiation: 18F-IRS<br>* According to experiment, 18F-IRS was non-toxic and stable in serum.<br>|
| Experimental: 18F-IRS:EGFR wild type<br>Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study. | Radiation: 18F-IRS<br>* According to experiment, 18F-IRS was non-toxic and stable in serum.<br>|
| Experimental: 18F-IRS:post-chemo EGFR wild type<br>Patients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study. | Radiation: 18F-IRS<br>* According to experiment, 18F-IRS was non-toxic and stable in serum.<br>|
| Experimental: 18F-IRS:unknown EGFR mutational status<br>Patients without the EGFR mutational status measurement results and did not receive any treatments were classified in this group | Radiation: 18F-IRS<br>* According to experiment, 18F-IRS was non-toxic and stable in serum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor SUVmax value of 18F-IRS PET/CT Imaging | To quantify the accumulation, a volume of interest using a 3-D sphere, was placed over the primary lung tumor, lymph nodes and distant metastases avoiding necrosis, blood vessels and normal lung tissue as much as possible on a workstation (Advantage Workstation 4.6; GE Healthcare). The maximum standard uptake value (SUVmax) normalized to body weight (kBq/mL) was calculated within the region of interest. | at time of imaging |