In Vivo EGFR Molecular Classification and Treatment Response

Molecular Imaging Clinical Trial

Official title:

An EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients Identification Strategy and Treatment Response Using Molecular Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02717221
• Other study ID #: 14400
• Status: Recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Harbin Medical University
• Contact: Xilin Sun, M.D.
• Phone: 86-15904601908
• Email: sunxilin[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Molecular Imaging

Intervention

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

Locations

Country	Name	City	State
China	TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor SUVmax value of 18F-MPG 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