Molecular ImagingNCT02717221
In Vivo EGFR Molecular Classification and Treatment Response
A study testing 18F-MPG in people with Molecular Imaging, run by Harbin Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Molecular Imaging
- What is being tested?
- 18F-MPG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Claustrophobia
- Pregnancy
- Metal implants in the thorax
Trial locations and contacts
1 site in 1 country.
China1 site
TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150028
About this study
Official title: An EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients Identification Strategy and Treatment Response Using Molecular Imaging
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.
Read the detailed 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.
- Conditions
- Molecular Imaging
- Being tested
- 18F-MPG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-MPGOther
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)
| Study group | Role | What they receive |
|---|---|---|
| 18F-MPG:EGFR+ | Experimental | Patients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study. Receives: Other: 18F-MPG |
| 18F-MPG:post-TKI EGFR+ | Experimental | Patients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study. Receives: Other: 18F-MPG |
| 18F-MPG:post-chemo EGFR+ | Experimental | Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study. Receives: 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. Receives: 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. Receives: 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 Receives: Other: 18F-MPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at time of imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startNov 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Molecular ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xilin Sun, Harbin Medical University
- Investigators
- Baozhong Shen, M.D., Study chair, The Fourth Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717221
- Sponsor's protocol ID
- 14400
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2016
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 25853020Abourbeh 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.
PubMed 25853010Petrulli 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.
PubMed 24403856Yeh 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.
PubMed 23956990Yeh 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.
PubMed 21220318Pal 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.
PubMed 20859697Zannetti 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.
PubMed 22331221Gerbaudo 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.
PubMed 28250852Nakamura 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.
PubMed 28151706
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients Identification Strategy and Treatment Response Using Molecular Imaging
- ClinicalTrials.gov ID
- NCT02717221
- Acronym / sponsor ID
- 14400
- Conditions
- Molecular Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 18F-MPG:EGFR+ | Experimental | Other: 18F-MPGPatients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study. |
| 18F-MPG:post-TKI EGFR+ | Experimental | Other: 18F-MPGPatients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study. |
| 18F-MPG:post-chemo EGFR+ | Experimental | Other: 18F-MPGPatients with EGFR-activating mutant tumors were receiving chemotherapy during this study. |
| 18F-MPG:EGFR wild type | Experimental | Other: 18F-MPGPatients in this group had EGFR wild-type tumors and did not receive any treatment before this study. |
| 18F-MPG:post-chemo EGFR wild type | Experimental | Other: 18F-MPGPatients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study. |
| 18F-MPG:unknown EGFR mutational status | Experimental | Other: 18F-MPGPatients without the EGFR mutational status measurement results and did not receive any treatments were classified in this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Claustrophobia
- Pregnancy
- Metal implants in the thorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-MPGN-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG) | Other | 18F-MPG:EGFR wild type, 18F-MPG:EGFR+, 18F-MPG:post-TKI EGFR+, 18F-MPG:post-chemo EGFR wild type, 18F-MPG:post-chemo EGFR+, 18F-MPG:unknown EGFR mutational status |
Primary outcome
tumor SUVmax value of 18F-MPG PET/CT Imaging
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 25853020Slobbe 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.
- Background: PubMed 25853010Abourbeh 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.
- Background: PubMed 24403856Petrulli 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.
- Background: PubMed 23956990Yeh 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.
- Background: PubMed 21220318Yeh 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.
- Background: PubMed 20859697Pal 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.
- Background: PubMed 22331221Zannetti 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.
- Background: PubMed 28250852Gerbaudo 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.
- Background: PubMed 28151706Nakamura 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baozhong Shen, M.D. study chair
The Fourth Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-MPG in people with Molecular Imaging, run by Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor SUVmax value of 18F-MPG PET/CT Imaging (time frame: at time of imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717221, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.