In Vivo EGFR-ECD Molecular Imaging Using [68Ga]- Labelling Anti-EGFR Affibody Molecule

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Targeted Molecular Imaging of [68Ga]- Labelling Anti-EGFR Affibody Molecule in EGFR ECD in Lung Cancer Patients and Healthy Volunteers

Conditions
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Molecular Imaging

Intervention / Treatment
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* Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-ZEGFR: EGFR++<br>Patients in this group had EGFR-activating mutant and EGFR high expression tumors and did not receive any treatment before this study. | Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907<br>* 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)<br>|
| Experimental: 68Ga-ZEGFR: EGFR+<br>Patients in this group had EGFR-activating mutant and EGFR medium expression tumors and did not receive any treatment before this study. | Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907<br>* 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)<br>|
| Experimental: 68Ga-ZEGFR: EGFR-<br>Patients in this group had no EGFR expression tumors and did not receive any treatment before this study. | Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907<br>* 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)<br>|
| Experimental: 68Ga-ZEGFR: EGFR wild type<br>Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study. | Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907<br>* 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)<br>|
| Experimental: 68Ga-ZEGFR:unknown EGFR status<br>Patients without the EGFR status measurement results and did not receive any treatments were classified in this group. | Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907<br>* 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)<br>|
| Experimental: 68Ga-ZEGFR: EGFR<br>Patients in this group had EGFR expression tumors and had receive some treatment before this study. | Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907<br>* 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |