EGFR Molecular Classification In Vivo

Not Applicable

Completed

• Conditions: Molecular Imaging
• Interventions: Radiation: 18F-IRS

• Registration Number: NCT03031522
• Lead Sponsor: Harbin Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-09-01
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-25
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
18F-IRS :post-TKI EGFR+ Patients	18F-IRS	Patients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study .
18F-IRS : EGFR+ Patients	18F-IRS	Patients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study.
18F-IRS:post-chemo EGFR wild type	18F-IRS	Patients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study.
18F-IRS:unknown EGFR mutational status	18F-IRS	Patients without the EGFR mutational status measurement results and did not receive any treatments were classified in this group
18F-IRS:EGFR wild type	18F-IRS	Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study.
18F-IRS:post-chemo EGFR+	18F-IRS	18F-IRS:post-chemo EGFR+ Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study.

Primary Outcome Measures

Name	Time	Method
tumor SUVmax value of 18F-IRS PET/CT Imaging	at time of 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.

Trial Locations

Locations (1)

TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China