EGFR Molecular Classification In Vivo

February 20, 2020 updated by: Yingying Sun, Harbin Medical University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150028
        • TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-IRS : EGFR+ Patients
Patients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study.
Radiation: 18F-IRS
According to experiment, 18F-IRS was non-toxic and stable in serum.
Experimental: 18F-IRS :post-TKI EGFR+ Patients
Patients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study .
Radiation: 18F-IRS
According to experiment, 18F-IRS was non-toxic and stable in serum.
Experimental: 18F-IRS:post-chemo EGFR+
18F-IRS:post-chemo EGFR+ Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study.
Radiation: 18F-IRS
According to experiment, 18F-IRS was non-toxic and stable in serum.
Experimental: 18F-IRS:EGFR wild type
Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study.
Radiation: 18F-IRS
According to experiment, 18F-IRS was non-toxic and stable in serum.
Experimental: 18F-IRS:post-chemo EGFR wild type
Patients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study.
Radiation: 18F-IRS
According to experiment, 18F-IRS was non-toxic and stable in serum.
Experimental: 18F-IRS:unknown EGFR mutational status
Patients without the EGFR mutational status measurement results and did not receive any treatments were classified in this group
Radiation: 18F-IRS
According to experiment, 18F-IRS was non-toxic and stable in serum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at time of imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harbin Medical University

Investigators

  • Study Chair: Baozhong Shen, M.D., The Fourth Hospital of Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 14006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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