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

NCT ID: NCT02916329

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-09-30

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.

Conditions

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Molecular Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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68Ga-ZEGFR: EGFR++

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

68Ga-ZEGFR: EGFR+

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

68Ga-ZEGFR: EGFR-

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

68Ga-ZEGFR: EGFR wild type

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

68Ga-ZEGFR:unknown EGFR status

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

68Ga-ZEGFR: EGFR

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xilin Sun

Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shen Baozhong, M.D.

Role: STUDY_CHAIR

The Fourth Hospital of Harbin Medical University

Locations

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

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Sun Xilin, M.D.

Role: CONTACT

86-15904601908

Facility Contacts

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Xilin Sun, M.D.

Role: primary

86-15904601908

Kai Wang, M.D.

Role: backup

86-13796601005

Other Identifiers

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14402

Identifier Type: -

Identifier Source: org_study_id

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