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EGFR Molecular Classification In Vivo

Sponsor
Harbin Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03031522
Collaborator
(none)
10
Enrollment
1
Location
6
Arms
64
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Radiation: 18F-IRS
 N/A

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 Design

Study Type:
Interventional
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 :
Sep 1, 2014
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. tumor SUVmax value of 18F-IRS PET/CT Imaging [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

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University Harbin Heilongjiang China 150028

Sponsors and Collaborators

  • Harbin Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yingying Sun, Chief, Harbin Medical University
ClinicalTrials.gov Identifier:
NCT03031522
Other Study ID Numbers:
  • 14006
First Posted:
Jan 25, 2017
Last Update Posted:
Feb 21, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 21, 2020