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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02916329

Enrollment

100

Registered

2016-09-27

Start date

2016-09-30

Completion date

2018-09-30

Last updated

2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molecular Imaging

Brief summary

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

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.

Interventions

OTHER68Ga-NODAGA-Ac-Cys-ZEGFR:1907

68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
tumor SUVmax value of 68Ga-NODAGA-ZEGFR:1907 PET/CT Imaging	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.

Countries

China

Contacts

Primary ContactSun Xilin, M.D.

sunxilin@aliyun.com86-15904601908

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026