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EGFR Molecular Classification In Vivo

Not Applicable
Completed
Conditions
Molecular Imaging
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.

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
Primary Outcome Measures
NameTimeMethod
tumor SUVmax value of 18F-IRS PET/CT Imagingat 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

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

🇨🇳

Harbin, Heilongjiang, China

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

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