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The investigators developed [68Ga]-labelling Anti-EGFR Affibody Molecule as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-ECD expression status.
The goals of investigators are to evaluate the use of [68Ga]-labelling Anti-EGFR Affibody Molecule as a novel PET/CT radiotracer to monitor EGFR-ECD expression status and classify EGFR-ECD benefit NSCLC patients. The investigators want to evaluated the use of [68Ga]-labelling Anti-EGFR Affibody Molecule in lung cancer imaging in adult NSCLC patients with different EGFR-ECD expression status of primary and metastatic cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-ZEGFR: EGFR++ | Experimental | Patients in this group had EGFR-activating mutant and EGFR high expression tumors and did not receive any treatment before this study. |
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| 68Ga-ZEGFR: EGFR+ | Experimental | Patients in this group had EGFR-activating mutant and EGFR medium expression tumors and did not receive any treatment before this study. |
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| 68Ga-ZEGFR: EGFR- | Experimental | Patients in this group had no EGFR expression tumors and did not receive any treatment before this study. |
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| 68Ga-ZEGFR: EGFR wild type | Experimental | Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study. |
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| 68Ga-ZEGFR:unknown EGFR status | Experimental | Patients without the EGFR status measurement results and did not receive any treatments were classified in this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 | Other | 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2) |
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| Measure | Description | Time Frame |
|---|---|---|
| tumor SUVmax value of 68Ga-NODAGA-ZEGFR:1907 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sun Xilin, M.D. | Contact | 86-15904601908 | sunxilin@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Shen Baozhong, M.D. | The Fourth Hospital of Harbin Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150028 | China |
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| 68Ga-ZEGFR: EGFR | Experimental | Patients in this group had EGFR expression tumors and had receive some treatment before this study. |
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