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EGFR Molecular Classification In Vivo

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03031522
Enrollment
10
Registered
2017-01-25
Start date
2014-09-01
Completion date
2019-12-31
Last updated
2020-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molecular Imaging

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.

Interventions

RADIATION18F-IRS

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

Sponsors

Harbin Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
tumor SUVmax value of 18F-IRS PET/CT Imagingat time of imagingTo 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026