In Vivo EGFR-ECD Molecular Imaging Using [68Ga]- Labelling Anti-EGFR Affibody Molecule
September 24, 2016 updated by: Xilin Sun, Harbin Medical University
Targeted Molecular Imaging of [68Ga]- Labelling Anti-EGFR Affibody Molecule in EGFR ECD in Lung Cancer Patients and Healthy Volunteers
The investigators developed [68Ga]-labelling Anti-EGFR Affibody Molecule as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-ECD expression status.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Heilongjiang
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Harbin, Heilongjiang, China, 150028
- Recruiting
- TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tumor SUVmax value of 68Ga-NODAGA-ZEGFR:1907 PET/CT Imaging
Time Frame: 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.
|
at time of imaging
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Shen Baozhong, M.D., The Fourth Hospital of Harbin Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (ANTICIPATED)
October 1, 2016
Study Completion (ANTICIPATED)
September 1, 2018
Study Registration Dates
First Submitted
September 24, 2016
First Submitted That Met QC Criteria
September 24, 2016
First Posted (ESTIMATE)
September 27, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
September 27, 2016
Last Update Submitted That Met QC Criteria
September 24, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 14402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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