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

Molecular Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02916329
• Other study ID #: 14402
• Status: Recruiting
• Phase: N/A
• First received: September 24, 2016
• Last updated: September 24, 2016
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2016
• Source: Harbin Medical University
• Contact: Sun Xilin, M.D.
• Phone: 86-15904601908
• Email: sunxilin[@]aliyun.com
• Is FDA regulated: No
• Health authority: China:The Fourth Hospital of Harbin Medical University
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Molecular Imaging

Intervention

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

Locations

Country	Name	City	State
China	TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes