CancerNCT03229772
Demonstration of the "SPECT/CT System With CZT Detectors" Imaging Performance in a Clinical Setting
A study testing Discovery NM/CT 670 CZT Imaging Scan in people with Cancer, run by GE Healthcare at 1 site in Israel.
Trial summary
The primary purpose of the study is to obtain sample clinical images that are evaluated by physicians in support of regulatory submissions. Additionally, the study will provide data for current and future product development and it will provide clinical images and data for marketing use. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- Discovery NM/CT 670 CZT Imaging Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to May 2016
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are 18-years old and older;
- is able to sign and date the informed consent form; AND
- have been prescribed by a physician a nuclear medicine exam that is within the intended use of the device.
Who cannot join
- Patients who were referred for dynamic nuclear medicine scan because of the need to be injected twice (once for the conventional acquisition and once for the investigational device) that would result in an increase dose burden on patient.
- Pregnant or lactating women
- Who were previously enrolled in this study;
- Who have contraindication for the radiopharmaceutical
- Who have any conditions that, in the opinion of the Investigator, would interfere with the evaluation of the results or constitute a health hazard for the subject;
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of the study is to obtain sample clinical images that are evaluated by physicians in support of regulatory submissions. Additionally, the study will provide data for current and future product development and it will provide clinical images and data for marketing use.
- Conditions
- Cancer
- Being tested
- Discovery NM/CT 670 CZT Imaging Scan
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discovery NM/CT 670 CZT Imaging ScanDevice
At a single visit, subjects will undergo nuclear medicine scintigraphy imaging scanning on the investigational GE Discovery 670 NM/CT CZT (with CZT) device and the commercial GE Discovery 670c (without CZT).
| Study group | Role | What they receive |
|---|---|---|
| Subjects indicated for dynamic nuclear medicine scanning | Other | The trial will consist of a single arm composed of subjects with preexisting indications for dynamic nuclear medicine scanning at the site. All patients will undergo nuclear medicine scintigraphy using the GE Discovery 670 NM/CT device with and without CZT enabled during a single visit. Receives: Device: Discovery NM/CT 670 CZT Imaging Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Image Quality
Diagnostic Image Quality will be rated by 2 radiologist using a 5 point Likert Scale
Measured: 12 weeks
Image Resolution
Image Resolution will be rated by 2 radiologist using a 5 point Likert Scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study startSep 2015
- Primary completionFeb 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zohar Keidar, MD, Principal investigator, Rambam Health Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229772
- Sponsor's protocol ID
- 117.02-2015-GES-0002
- Status last verified
- Jul 2017
- First submitted
- 11 May 2016
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of the "SPECT/CT System With CZT Detectors" Imaging Performance in a Clinical Setting
- ClinicalTrials.gov ID
- NCT03229772
- Acronym / sponsor ID
- 117.02-2015-GES-0002
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 26 Jul 2017 (actual)
- 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 primary purpose of the study is to obtain sample clinical images that are evaluated by physicians in support of regulatory submissions. Additionally, the study will provide data for current and future product development and it will provide clinical images and data for marketing use.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects indicated for dynamic nuclear medicine scanning | Other | Device: Discovery NM/CT 670 CZT Imaging ScanThe trial will consist of a single arm composed of subjects with preexisting indications for dynamic nuclear medicine scanning at the site. All patients will undergo nuclear medicine scintigraphy using the GE Discovery 670 NM/CT device with and without CZT enabled during a single visit. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- are 18-years old and older;
- is able to sign and date the informed consent form; AND
- have been prescribed by a physician a nuclear medicine exam that is within the intended use of the device.
Key exclusion criteria (5 listed)
- Patients who were referred for dynamic nuclear medicine scan because of the need to be injected twice (once for the conventional acquisition and once for the investigational device) that would result in an increase dose burden on patient.
- Pregnant or lactating women
- Who were previously enrolled in this study;
- Who have contraindication for the radiopharmaceutical
- Who have any conditions that, in the opinion of the Investigator, would interfere with the evaluation of the results or constitute a health hazard for the subject;
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 |
|---|---|---|
| Discovery NM/CT 670 CZT Imaging ScanAt a single visit, subjects will undergo nuclear medicine scintigraphy imaging scanning on the investigational GE Discovery 670 NM/CT CZT (with CZT) device and the commercial GE Discovery 670c (without CZT). | Device | Subjects indicated for dynamic nuclear medicine scanning |
Primary outcome
Diagnostic Image Quality
Time frame: 12 weeks
Diagnostic Image Quality will be rated by 2 radiologist using a 5 point Likert Scale
Image Resolution
Time frame: 12 weeks
Image Resolution will be rated by 2 radiologist using a 5 point Likert Scale
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 26 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Zohar Keidar, MD principal investigator
Rambam Health Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discovery NM/CT 670 CZT Imaging Scan in people with Cancer, run by GE Healthcare at 1 site in Israel.
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 3 inclusion and 5 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 26 Jul 2017. 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 Israel. 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?
Diagnostic Image Quality (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 26 Jul 2017.