NCT02717221

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

5.1 years

First QC Date

March 8, 2016

Last Update Submit

March 28, 2025

Conditions

Molecular Imaging

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

18F-MPG:EGFR+

EXPERIMENTAL

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

Other: 18F-MPG

18F-MPG:post-TKI EGFR+

EXPERIMENTAL

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

Other: 18F-MPG

18F-MPG:post-chemo EGFR+

EXPERIMENTAL

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

Other: 18F-MPG

18F-MPG:EGFR wild type

EXPERIMENTAL

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

Other: 18F-MPG

18F-MPG:post-chemo EGFR wild type

EXPERIMENTAL

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

Other: 18F-MPG

18F-MPG:unknown EGFR mutational status

EXPERIMENTAL

Patients without the EGFR mutational status measurement results and did not receive any treatments were classified in this group

Other: 18F-MPG

Interventions

18F-MPGOTHER

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 type18F-MPG:EGFR+18F-MPG:post-TKI EGFR+18F-MPG:post-chemo EGFR wild type18F-MPG:post-chemo EGFR+18F-MPG:unknown EGFR mutational status

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Related Publications (9)

  • 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.

    PMID: 25853020BACKGROUND

  • 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.

    PMID: 25853010BACKGROUND

  • 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.

    PMID: 24403856BACKGROUND

  • 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.

    PMID: 23956990BACKGROUND

  • 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.

    PMID: 21220318BACKGROUND

  • 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.

    PMID: 20859697BACKGROUND

  • 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.

    PMID: 22331221BACKGROUND

  • 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.

    PMID: 28250852BACKGROUND

  • 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.

    PMID: 28151706BACKGROUND

Study Officials

  • Baozhong Shen, M.D.

    The Fourth Hospital of Harbin Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 23, 2016

Study Start

November 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 2, 2025

Record last verified: 2025-03

Locations

CN(1)