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

Harbin Medical University

Status: Unknown

Conditions: Molecular Imaging

Treatments: Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907

Study type: Interventional

Funder types: Other

Identifiers

NCT02916329

14402

Details and patient eligibility

About

The investigators developed [68Ga]-labelling Anti-EGFR Affibody Molecule as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-ECD expression status.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 6 patient groups

68Ga-ZEGFR: EGFR++

Experimental group

Description:

Patients in this group had EGFR-activating mutant and EGFR high expression tumors and did not receive any treatment before this study.

Treatment:

Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907

68Ga-ZEGFR: EGFR+

Experimental group

Description:

Patients in this group had EGFR-activating mutant and EGFR medium expression tumors and did not receive any treatment before this study.

Treatment:

Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907

68Ga-ZEGFR: EGFR-

Experimental group

Description:

Patients in this group had no EGFR expression tumors and did not receive any treatment before this study.

Treatment:

Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907

68Ga-ZEGFR: EGFR wild type

Experimental group

Description:

Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study.

Treatment:

Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907

68Ga-ZEGFR:unknown EGFR status

Experimental group

Description:

Patients without the EGFR status measurement results and did not receive any treatments were classified in this group.

Treatment:

Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907

68Ga-ZEGFR: EGFR

Experimental group

Description:

Patients in this group had EGFR expression tumors and had receive some treatment before this study.

Treatment:

Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907