Molecular ImagingNCT03031522
EGFR Molecular Classification In Vivo
A study testing 18F-IRS in people with Molecular Imaging, run by Harbin Medical University at 1 site in China.
Trial summary
The investigators developed 18F-IRS as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-activating mutational status. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Molecular Imaging
- What is being tested?
- 18F-IRS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2014to 31 Dec 2019
- 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 to 75 years
- 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
TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150028
About this study
Official title: Molecular Imaging to Identify EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients
The investigators developed 18F-IRS as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-activating mutational status.
Read the detailed description
The goal of investigators were to evaluate the use of 18F-IRS as a novel PET/CT radiotracer to monitor EGFR-activating mutational status and identify EGFR-TKIs benefit NSCLC patients. the investigators want to evaluated the use of 18F-IRS in lung cancer imaging in adult NSCLC patients with different EGFR mutational status of primary and metastatic cancers.
- Conditions
- Molecular Imaging
- Being tested
- 18F-IRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-IRSRadiation
According to experiment, 18F-IRS was non-toxic and stable in serum.
| Study group | Role | What they receive |
|---|---|---|
| 18F-IRS : EGFR+ Patients | Experimental | Patients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study. Receives: Radiation: 18F-IRS |
| 18F-IRS :post-TKI EGFR+ Patients | Experimental | Patients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study . Receives: Radiation: 18F-IRS |
| 18F-IRS:post-chemo EGFR+ | Experimental | 18F-IRS:post-chemo EGFR+ Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study. Receives: Radiation: 18F-IRS |
| 18F-IRS:EGFR wild type | Experimental | Patients in this group had EGFR wild-type tumors and did not receive any treatment before this study. Receives: Radiation: 18F-IRS |
| 18F-IRS:post-chemo EGFR wild type | Experimental | Patients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study. Receives: Radiation: 18F-IRS |
| 18F-IRS:unknown EGFR mutational status | Experimental | Patients without the EGFR mutational status measurement results and did not receive any treatments were classified in this group Receives: Radiation: 18F-IRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor SUVmax value of 18F-IRS 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 posted25 Jan 2017 (estimated)
- Study start1 Sep 2014
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingying Sun, Harbin Medical University
- Investigators
- Baozhong Shen, M.D., Study chair, The Fourth Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031522
- Sponsor's protocol ID
- 14006
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2017
- Last updated
- 21 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging to Identify EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients
- ClinicalTrials.gov ID
- NCT03031522
- Acronym / sponsor ID
- 14006
- Conditions
- Molecular Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Jan 2017 (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 18F-IRS as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-activating mutational status.
Detailed description
The goal of investigators were to evaluate the use of 18F-IRS as a novel PET/CT radiotracer to monitor EGFR-activating mutational status and identify EGFR-TKIs benefit NSCLC patients. the investigators want to evaluated the use of 18F-IRS in lung cancer imaging in adult NSCLC patients with different EGFR mutational 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 |
|---|---|---|
| 18F-IRS : EGFR+ Patients | Experimental | Radiation: 18F-IRSPatients in this group had EGFR-activating mutant tumors and did not receive any treatment before this study. |
| 18F-IRS :post-TKI EGFR+ Patients | Experimental | Radiation: 18F-IRSPatients with EGFR-activating mutant tumors were receiving EGFR-TKIs during this study . |
| 18F-IRS:post-chemo EGFR+ | Experimental | Radiation: 18F-IRS18F-IRS:post-chemo EGFR+ Patients with EGFR-activating mutant tumors were receiving chemotherapy during this study. |
| 18F-IRS:EGFR wild type | Experimental | Radiation: 18F-IRSPatients in this group had EGFR wild-type tumors and did not receive any treatment before this study. |
| 18F-IRS:post-chemo EGFR wild type | Experimental | Radiation: 18F-IRSPatients in this group had EGFR wild-type tumors and were receiving chemotherapy during this study. |
| 18F-IRS:unknown EGFR mutational status | Experimental | Radiation: 18F-IRSPatients without the EGFR mutational status measurement results and did not receive any treatments were classified in this group |
Who may qualify
- Ages
- 18 to 75 years
- 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 |
|---|---|---|
| 18F-IRSAccording to experiment, 18F-IRS was non-toxic and stable in serum. | Radiation | 18F-IRS : EGFR+ Patients, 18F-IRS :post-TKI EGFR+ Patients, 18F-IRS:EGFR wild type, 18F-IRS:post-chemo EGFR wild type, 18F-IRS:post-chemo EGFR+, 18F-IRS:unknown EGFR mutational status |
Primary outcome
tumor SUVmax value of 18F-IRS 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- 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.
Baozhong Shen, 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 18F-IRS 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: finished, as of the sponsor's last update on 21 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor SUVmax value of 18F-IRS 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 21 Feb 2020.