In Vivo EGFR Molecular Classification and Treatment Response

June 23, 2019 updated by: Xilin Sun, Harbin Medical University

An EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients Identification Strategy and Treatment Response Using Molecular Imaging

The investigators developed 18F-MPG as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-activating mutational status. And use 18F-MPG to monitor EGFR-TKIs and chemotherapy treatment efficiency.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The goal of investigators were to evaluate the use of 18F-MPG 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-MPG in lung cancer imaging in adult NSCLC patients with different EGFR mutational status of primary and metastatic cancers. And the investigators want to evaluated the use of 18F-MPG in adult NSCLC patients with EGFR mutational status received non-treatment, EGFR-TKIs and chemotherapy.

Study Type

Interventional

Enrollment (Anticipated)

100

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
        • Recruiting
        • 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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-MPG:EGFR+
Patients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study.
Other: 18F-MPG
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)
Experimental: 18F-MPG:post-TKI EGFR+
Patients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study.
Other: 18F-MPG
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)
Experimental: 18F-MPG:post-chemo EGFR+
Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study.
Other: 18F-MPG
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)
Experimental: 18F-MPG:EGFR wild type
Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study.
Other: 18F-MPG
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)
Experimental: 18F-MPG:post-chemo EGFR wild type
Patients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study.
Other: 18F-MPG
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)
Experimental: 18F-MPG:unknown EGFR mutational status
Patients without the EGFR mutational status measurement results and did not receive any treatments were classified in this group
Other: 18F-MPG
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor SUVmax value of 18F-MPG 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2014

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 23, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 14400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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