In Vivo EGFR Molecular Classification and Treatment Response

NCT ID: NCT02717221

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Molecular Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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18F-MPG:EGFR+

Patients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study.

Group Type EXPERIMENTAL

18F-MPG

Intervention Type OTHER

N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-\[18F\] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)

18F-MPG:post-TKI EGFR+

Patients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study.

Group Type EXPERIMENTAL

18F-MPG

Intervention Type OTHER

N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-\[18F\] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)

18F-MPG:post-chemo EGFR+

Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study.

Group Type EXPERIMENTAL

18F-MPG

Intervention Type OTHER

N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-\[18F\] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)

18F-MPG:EGFR wild type

Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study.

Group Type EXPERIMENTAL

18F-MPG

Intervention Type OTHER

N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-\[18F\] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)

18F-MPG:post-chemo EGFR wild type

Patients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study.

Group Type EXPERIMENTAL

18F-MPG

Intervention Type OTHER

N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-\[18F\] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)

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

Group Type EXPERIMENTAL

18F-MPG

Intervention Type OTHER

N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-\[18F\] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)

Interventions

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18F-MPG

N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-\[18F\] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xilin Sun

Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baozhong Shen, M.D.

Role: STUDY_CHAIR

The Fourth Hospital of Harbin Medical University

Locations

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TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

Countries

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China

References

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Slobbe P, Windhorst AD, Stigter-van Walsum M, Smit EF, Niessen HG, Solca F, Stehle G, van Dongen GA, Poot AJ. A comparative PET imaging study with the reversible and irreversible EGFR tyrosine kinase inhibitors [(11)C]erlotinib and [(18)F]afatinib in lung cancer-bearing mice. EJNMMI Res. 2015 Mar 20;5:14. doi: 10.1186/s13550-015-0088-0. eCollection 2015.

Reference Type BACKGROUND
PMID: 25853020 (View on PubMed)

Abourbeh G, Itamar B, Salnikov O, Beltsov S, Mishani E. Identifying erlotinib-sensitive non-small cell lung carcinoma tumors in mice using [(11)C]erlotinib PET. EJNMMI Res. 2015 Feb 12;5:4. doi: 10.1186/s13550-014-0080-0. eCollection 2015.

Reference Type BACKGROUND
PMID: 25853010 (View on PubMed)

Petrulli JR, Sullivan JM, Zheng MQ, Bennett DC, Charest J, Huang Y, Morris ED, Contessa JN. Quantitative analysis of [11C]-erlotinib PET demonstrates specific binding for activating mutations of the EGFR kinase domain. Neoplasia. 2013 Dec;15(12):1347-53. doi: 10.1593/neo.131666.

Reference Type BACKGROUND
PMID: 24403856 (View on PubMed)

Yeh SH, Lin CF, Kong FL, Wang HE, Hsieh YJ, Gelovani JG, Liu RS. Molecular imaging of nonsmall cell lung carcinomas expressing active mutant EGFR kinase using PET with [(124)i]-morpholino-IPQA. Biomed Res Int. 2013;2013:549359. doi: 10.1155/2013/549359. Epub 2013 Jul 17.

Reference Type BACKGROUND
PMID: 23956990 (View on PubMed)

Yeh HH, Ogawa K, Balatoni J, Mukhapadhyay U, Pal A, Gonzalez-Lepera C, Shavrin A, Soghomonyan S, Flores L 2nd, Young D, Volgin AY, Najjar AM, Krasnykh V, Tong W, Alauddin MM, Gelovani JG. Molecular imaging of active mutant L858R EGF receptor (EGFR) kinase-expressing nonsmall cell lung carcinomas using PET/CT. Proc Natl Acad Sci U S A. 2011 Jan 25;108(4):1603-8. doi: 10.1073/pnas.1010744108. Epub 2011 Jan 10.

Reference Type BACKGROUND
PMID: 21220318 (View on PubMed)

Pal A, Balatoni JA, Mukhopadhyay U, Ogawa K, Gonzalez-Lepera C, Shavrin A, Volgin A, Tong W, Alauddin MM, Gelovani JG. Radiosynthesis and initial in vitro evaluation of [18F]F-PEG6-IPQA--a novel PET radiotracer for imaging EGFR expression-activity in lung carcinomas. Mol Imaging Biol. 2011 Oct;13(5):853-61. doi: 10.1007/s11307-010-0408-8.

Reference Type BACKGROUND
PMID: 20859697 (View on PubMed)

Zannetti A, Iommelli F, Speranza A, Salvatore M, Del Vecchio S. 3'-deoxy-3'-18F-fluorothymidine PET/CT to guide therapy with epidermal growth factor receptor antagonists and Bcl-xL inhibitors in non-small cell lung cancer. J Nucl Med. 2012 Mar;53(3):443-50. doi: 10.2967/jnumed.111.096503. Epub 2012 Feb 13.

Reference Type BACKGROUND
PMID: 22331221 (View on PubMed)

Gerbaudo VH, Kim CK. PET Imaging-Based Phenotyping as a Predictive Biomarker of Response to Tyrosine Kinase Inhibitor Therapy in Non-small Cell Lung Cancer: Are We There Yet? Nucl Med Mol Imaging. 2017 Mar;51(1):3-10. doi: 10.1007/s13139-016-0453-6. Epub 2016 Oct 11.

Reference Type BACKGROUND
PMID: 28250852 (View on PubMed)

Nakamura Y, Ohler ZW, Householder D, Nagaya T, Sato K, Okuyama S, Ogata F, Daar D, Hoa T, Choyke PL, Kobayashi H. Near Infrared Photoimmunotherapy in a Transgenic Mouse Model of Spontaneous Epidermal Growth Factor Receptor (EGFR)-expressing Lung Cancer. Mol Cancer Ther. 2017 Feb;16(2):408-414. doi: 10.1158/1535-7163.MCT-16-0663. Epub 2016 Nov 15.

Reference Type BACKGROUND
PMID: 28151706 (View on PubMed)

Other Identifiers

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14400

Identifier Type: -

Identifier Source: org_study_id

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