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

Sponsor

Harbin Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02916329

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Molecular Imaging	Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)
Experimental: 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.	Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)
Experimental: 68Ga-ZEGFR: EGFR- Patients in this group had no EGFR expression tumors and did not receive any treatment before this study.	Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)
Experimental: 68Ga-ZEGFR: EGFR wild type Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study.	Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)
Experimental: 68Ga-ZEGFR:unknown EGFR status Patients without the EGFR status measurement results and did not receive any treatments were classified in this group.	Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)
Experimental: 68Ga-ZEGFR: EGFR Patients in this group had EGFR expression tumors and had receive some treatment before this study.	Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150028

Sponsors and Collaborators

Harbin Medical University

Investigators

Study Chair: Shen Baozhong, M.D., The Fourth Hospital of Harbin Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xilin Sun, Chief, Harbin Medical University

ClinicalTrials.gov Identifier:

NCT02916329

Other Study ID Numbers:

14402

First Posted:

Sep 27, 2016

Last Update Posted:

Sep 27, 2016

Last Verified:

Sep 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Study Results

No Results Posted as of Sep 27, 2016