EGFR Molecular Classification In Vivo

Molecular Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031522
• Other study ID #: 14006
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Molecular Imaging

Intervention

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

Locations

Country	Name	City	State
China	TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor SUVmax value of 18F-IRS PET/CT 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.	at time of imaging