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

Not Applicable
Conditions
Molecular Imaging
Registration Number
NCT02916329
Lead Sponsor
Harbin Medical University
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
tumor SUVmax value of 68Ga-NODAGA-ZEGFR:1907 PET/CT Imagingat 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University

🇨🇳

Harbin, Heilongjiang, China

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