In Vivo EGFR Molecular Classification and Treatment Response
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ClinicalTrials.gov Identifier: NCT02717221 |
Recruitment Status : Unknown
Verified March 2019 by Xilin Sun, Harbin Medical University.
Recruitment status was: Recruiting
First Posted : March 23, 2016
Last Update Posted : June 25, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Molecular Imaging | Other: 18F-MPG | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | An EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients Identification Strategy and Treatment Response Using Molecular Imaging |
Study Start Date : | November 2014 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: 18F-MPG:EGFR+
Patients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study.
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Other: 18F-MPG
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG) |
Experimental: 18F-MPG:post-TKI EGFR+
Patients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study.
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Other: 18F-MPG
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG) |
Experimental: 18F-MPG:post-chemo EGFR+
Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study.
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Other: 18F-MPG
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG) |
Experimental: 18F-MPG:EGFR wild type
Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study.
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Other: 18F-MPG
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG) |
Experimental: 18F-MPG:post-chemo EGFR wild type
Patients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study.
|
Other: 18F-MPG
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG) |
Experimental: 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
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Other: 18F-MPG
N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG) |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717221
Contact: Xilin Sun, M.D. | 86-15904601908 | sunxilin@aliyun.com |
China, Heilongjiang | |
TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University | Recruiting |
Harbin, Heilongjiang, China, 150028 | |
Contact: Xilin Sun, M.D. 86-15904601908 sunxilin@aliyun.com | |
Contact: Kai Wang, M.D. 86-13796601005 wangkai366@126.com |
Study Chair: | Baozhong Shen, M.D. | The Fourth Hospital of Harbin Medical University |
Responsible Party: | Xilin Sun, Chief, Harbin Medical University |
ClinicalTrials.gov Identifier: | NCT02717221 |
Other Study ID Numbers: |
14400 |
First Posted: | March 23, 2016 Key Record Dates |
Last Update Posted: | June 25, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |