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EGFR Molecular Classification In Vivo

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031522
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Yingying Sun, Harbin Medical University

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

Condition or disease Intervention/treatment Phase
Molecular Imaging Radiation: 18F-IRS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Molecular Imaging to Identify EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (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

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): NCT03031522


Locations
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China, Heilongjiang
TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150028
Sponsors and Collaborators
Harbin Medical University
Investigators
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Study Chair: Baozhong Shen, M.D. The Fourth Hospital of Harbin Medical University
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Responsible Party: Yingying Sun, Chief, Harbin Medical University
ClinicalTrials.gov Identifier: NCT03031522    
Other Study ID Numbers: 14006
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No