Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

In Vivo EGFR Molecular Classification and Treatment Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02717221
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Xilin Sun, Harbin Medical University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Molecular Imaging Other: 18F-MPG Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: An EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients Identification Strategy and Treatment Response Using Molecular Imaging
Study Start Date : November 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717221


Contacts
Layout table for location contacts
Contact: Xilin Sun, M.D. 86-15904601908 sunxilin@aliyun.com

Locations
Layout table for location information
China, Heilongjiang
TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150028
Contact: Xilin Sun, M.D.    86-15904601908    sunxilin@aliyun.com   
Contact: Kai Wang, M.D.    86-13796601005    wangkai366@126.com   
Sponsors and Collaborators
Harbin Medical University
Investigators
Layout table for investigator information
Study Chair: Baozhong Shen, M.D. The Fourth Hospital of Harbin Medical University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Layout table for additonal information
Responsible Party: Xilin Sun, Chief, Harbin Medical University
ClinicalTrials.gov Identifier: NCT02717221     History of Changes
Other Study ID Numbers: 14400
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided