In Vivo EGFR Molecular Classification and Treatment Response

Not Applicable

Completed

• Conditions: Molecular Imaging
• Interventions: Other: 18F-MPG

• Registration Number: NCT02717221
• Lead Sponsor: Harbin Medical University

Brief Summary

The investigators developed 18F-MPG as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-activating mutational status. And use 18F-MPG to monitor EGFR-TKIs and chemotherapy treatment efficiency.

Detailed Description

The goal of investigators were to evaluate the use of 18F-MPG 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-MPG in lung cancer imaging in adult NSCLC patients with different EGFR mutational status of primary and metastatic cancers. And the investigators want to evaluated the use of 18F-MPG in adult NSCLC patients with EGFR mutational status received non-treatment, EGFR-TKIs and chemotherapy.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-23
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Primary Outcome Measures

Name	Time	Method
tumor SUVmax value of 18F-MPG 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