Molecular ImagingNCT02916329
In Vivo EGFR-ECD Molecular Imaging Using [68Ga]- Labelling Anti-EGFR Affibody Molecule
A study testing 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 in people with Molecular Imaging, run by Harbin Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Molecular Imaging
- What is being tested?
- 68Ga-NODAGA-Ac-Cys-ZEGFR:1907
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Claustrophobia
- Pregnancy
- Metal implants in the thorax
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150028
Xilin Sun, M.D., 86-15904601908, sunxilin@aliyun.com
Kai Wang, M.D., 86-13796601005, wangkai366@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Molecular Imaging
- Being tested
- 68Ga-NODAGA-Ac-Cys-ZEGFR:1907
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-Ac-Cys-ZEGFR:1907Other
68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-ZEGFR: EGFR++ | Experimental | Patients in this group had EGFR-activating mutant and EGFR high expression tumors and did not receive any treatment before this study. Receives: Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 |
| 68Ga-ZEGFR: EGFR+ | Experimental | Patients in this group had EGFR-activating mutant and EGFR medium expression tumors and did not receive any treatment before this study. Receives: Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 |
| 68Ga-ZEGFR: EGFR- | Experimental | Patients in this group had no EGFR expression tumors and did not receive any treatment before this study. Receives: Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 |
| 68Ga-ZEGFR: EGFR wild type | Experimental | Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study. Receives: Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 |
| 68Ga-ZEGFR:unknown EGFR status | Experimental | Patients without the EGFR status measurement results and did not receive any treatments were classified in this group. Receives: Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 |
| 68Ga-ZEGFR: EGFR | Experimental | Patients in this group had EGFR expression tumors and had receive some treatment before this study. Receives: Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at time of imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2016 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molecular ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xilin Sun, Harbin Medical University
- Investigators
- Shen Baozhong, M.D., Study chair, The Fourth Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916329
- Sponsor's protocol ID
- 14402
- Status last verified
- Sep 2016
- First submitted
- 24 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Molecular Imaging of [68Ga]- Labelling Anti-EGFR Affibody Molecule in EGFR ECD in Lung Cancer Patients and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02916329
- Acronym / sponsor ID
- 14402
- Conditions
- Molecular Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 68Ga-ZEGFR: EGFR++ | Experimental | Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907Patients in this group had EGFR-activating mutant and EGFR high expression tumors and did not receive any treatment before this study. |
| 68Ga-ZEGFR: EGFR+ | Experimental | Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907Patients in this group had EGFR-activating mutant and EGFR medium expression tumors and did not receive any treatment before this study. |
| 68Ga-ZEGFR: EGFR- | Experimental | Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907Patients in this group had no EGFR expression tumors and did not receive any treatment before this study. |
| 68Ga-ZEGFR: EGFR wild type | Experimental | Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study. |
| 68Ga-ZEGFR:unknown EGFR status | Experimental | Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907Patients without the EGFR status measurement results and did not receive any treatments were classified in this group. |
| 68Ga-ZEGFR: EGFR | Experimental | Other: 68Ga-NODAGA-Ac-Cys-ZEGFR:1907Patients in this group had EGFR expression tumors and had receive some treatment before this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Claustrophobia
- Pregnancy
- Metal implants in the thorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NODAGA-Ac-Cys-ZEGFR:190768Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2) | Other | 68Ga-ZEGFR: EGFR, 68Ga-ZEGFR: EGFR wild type, 68Ga-ZEGFR: EGFR+, 68Ga-ZEGFR: EGFR++, 68Ga-ZEGFR: EGFR-, 68Ga-ZEGFR:unknown EGFR status |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shen Baozhong, M.D. study chair
The Fourth Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-NODAGA-Ac-Cys-ZEGFR:1907 in people with Molecular Imaging, run by Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Xilin, M.D. (86-15904601908, sunxilin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor SUVmax value of 68Ga-NODAGA-ZEGFR:1907 PET/CT Imaging (time frame: at time of imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.