EGFR Molecular Classification In Vivo
Molecular Imaging to Identify EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients
1 other identifier
interventional
10
1 country
1
Brief Summary
The investigators developed 18F-IRS as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-activating mutational status.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 23, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 21, 2020
January 1, 2020
5.3 years
January 23, 2017
February 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
tumor SUVmax value of 18F-IRS PET/CT 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
Study Arms (6)
18F-IRS : EGFR+ Patients
EXPERIMENTALPatients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study.
18F-IRS :post-TKI EGFR+ Patients
EXPERIMENTALPatients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study .
18F-IRS:post-chemo EGFR+
EXPERIMENTAL18F-IRS:post-chemo EGFR+ Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study.
18F-IRS:EGFR wild type
EXPERIMENTALPatients in this group had EGFR wild-type tumors and did not receive any treatment before this study.
18F-IRS:post-chemo EGFR wild type
EXPERIMENTALPatients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study.
18F-IRS:unknown EGFR mutational status
EXPERIMENTALPatients without the EGFR mutational status measurement results and did not receive any treatments were classified in this group
Interventions
According to experiment, 18F-IRS was non-toxic and stable in serum.
Eligibility Criteria
You may qualify if:
- Advanced NSCLC
- 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
You may not qualify if:
- Claustrophobia
- Pregnancy
- Metal implants in the thorax
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150028, China
Study Officials
- STUDY CHAIR
Baozhong Shen, M.D.
The Fourth Hospital of Harbin Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief
Study Record Dates
First Submitted
January 23, 2017
First Posted
January 25, 2017
Study Start
September 1, 2014
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
February 21, 2020
Record last verified: 2020-01