Detect Pathalogical LesionsGP_D-SpectNCT00979355
Study to Compare a Fast Gama Camera for Nuclear Imaging to Conventional Camera
A study testing GP-D-SPECT in people with Detect Pathalogical Lesions, run by Spectrum Dynamics at 1 site in Israel.
Trial summary
A feasibility trial to evaluate the usefulness of a high efficiency camera (D-SPECT) as an imaging modality for general nuclear medicine applications such as oncology. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Detect Pathalogical Lesions
- What is being tested?
- GP-D-SPECT
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to Dec 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is referred to nuclear medicine department for a SPECT scan.
- Written informed consent is obtained by a study investigator.
Who cannot join
- Patient pregnancy (known or suspected).
- Lack of written informed consent
- Prisoner status
- Patient under age 18 or over 80 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Multi Purpose D-spect Camera for General Nuclear Scans
A feasibility trial to evaluate the usefulness of a high efficiency camera (D-SPECT) as an imaging modality for general nuclear medicine applications such as oncology.
- Conditions
- Detect Pathalogical Lesions
- Being tested
- GP-D-SPECT
- Keywords
- Whole body, SPECT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP-D-SPECTDevice
The D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large PMTs. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient.
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to the ability to detect pathological lesions.
Measured: 12 month
Secondary outcomes (1)
A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to image quality/resolution
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Detect Pathalogical LesionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Dynamics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MIGUEL GORENBERG, MD, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979355
- Sponsor's protocol ID
- GP- DSpect_001
- Acronym
- GP_D-Spect
- Status last verified
- Jun 2019
- First submitted
- 17 Sep 2009
- Last updated
- 14 Jun 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Multi Purpose D-spect Camera for General Nuclear Scans
- ClinicalTrials.gov ID
- NCT00979355
- Acronym / sponsor ID
- GP_D-Spect / GP- DSpect_001
- Conditions
- Detect Pathalogical Lesions
- Keywords
- Whole body, SPECT
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Spectrum DynamicsIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 Sep 2009 (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.
A feasibility trial to evaluate the usefulness of a high efficiency camera (D-SPECT) as an imaging modality for general nuclear medicine applications such as oncology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is referred to nuclear medicine department for a SPECT scan.
- Written informed consent is obtained by a study investigator.
Key exclusion criteria (4 listed)
- Patient pregnancy (known or suspected).
- Lack of written informed consent
- Prisoner status
- Patient under age 18 or over 80 years old.
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 |
|---|---|---|
| GP-D-SPECTThe D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large PMTs. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient. | Device | – |
Primary outcome
A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to the ability to detect pathological lesions.
Time frame: 12 month
1 secondary outcome
A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to image quality/resolution
Time frame: 12 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
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.
MIGUEL GORENBERG, MD principal investigator
Bnai Zion Medical 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 GP-D-SPECT in people with Detect Pathalogical Lesions, run by Spectrum Dynamics 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 14 Jun 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to the ability to detect pathological lesions. (time frame: 12 month). 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 14 Jun 2019.