EGFR Molecular Classification In Vivo

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Molecular Imaging

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University

Harbin, Heilongjiang, 150028, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

18F-IRS

Radiation

According to experiment, 18F-IRS was non-toxic and stable in serum.

Primary outcomes

tumor SUVmax value of 18F-IRS PET/CT Imaging

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Jan 25, 2017
Registry last updated: Feb 21, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed