PET ImagingNCT03490812
Assessment of Investigational Positron Emission Tomography and Post-Processing Procedures Performed as Add-ons to Standard of Care Imaging
A study testing PET scan and Retrospective data analysis in people with PET Imaging, run by University of Cincinnati at 1 site in United States.
Trial summary
The goals of this study are to (1) develop and refine PET post-processing acquisition procedures, (2) generate preliminary and comparative imaging data for potential clinical trials, and (3) retrospectively evaluate standard of care PET imaging acquisitions by comparison with investigational PET imaging acquisitions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PET Imaging
- What is being tested?
- PET scan and Retrospective data analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2015to 31 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female volunteers greater than or equal to 18 years of age
- Patients receiving a standard of care PET scan at OSU
- Male and female patients greater than or equal to 18 years of age
- Patients who have previously received a standard of care PET scan at OSU
Who cannot join
- Participants who are pregnant or lactating
- Prisoners
- Subjects incapable of giving informed written consent
- Retrospective Population:
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43221
About this study
The goals of this study are to (1) develop and refine PET post-processing acquisition procedures, (2) generate preliminary and comparative imaging data for potential clinical trials, and (3) retrospectively evaluate standard of care PET imaging acquisitions by comparison with investigational PET imaging acquisitions.
Read the detailed description
The prospective portion of study will utilize investigational PET acquisitions in addition to standard of care PET imaging to develop and optimize PET acquisition post-processing techniques as well as to generate preliminary and comparative data for potential clinical trials. These post-processing techniques include but are not limited to visual inspection of lesions, normal tissue, sentinel nodes and imaging artifacts, semi-quantitative analysis including the use of rating schemes, and using various published methods for image post-processing. The PET methodologies we plan to use as part of this study will allow us to obtain morphological, functional and molecular information. Patients receiving a standard of care PET will be asked by study personnel if they are interested in undergoing additional investigational acquisitions before or after their standard of care imaging. If the patient agrees, he/she will remain on the same PET scanner for up to an additional 30 minutes while more images are obtained. Each patient will be imaged for no longer than 2 hours (standard of care imaging and additional investigational imaging). A routine clinical report will be generated for the clinically indicated PET by a nuclear medicine physician. Once this routine clinical PET scan is dictated and finalized, a study team member will obtain the report via IHIS and manually remove all identifiers. This report is being obtained for comparative purposes. All the data being compared will be coded using a unique study number. The retrospective portion of this study will involve the review of pre-existing data from January 1, 2001 through December 5, 2017. The data to be reviewed/analyzed includes PET imaging data that has been previously collected in the course of standard clinical care. The PET imaging acquisitions obtained from the retrospective review will be utilized as a comparison to the investigational images obtained during the prospective portion of this study. The criteria that will be utilized to determine how the retrospective data will be utilized includes the following parameters: type of imaging study, diagnosis, age in decades, gender, and availability of data in the imaging archive.
- Conditions
- PET Imaging
- Being tested
- PET scan, Retrospective data analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scanDiagnostic test
Investigational PET scan as add-on to standard-of-care scan
Retrospective data analysisOther
Review of pre-existing data from January 1, 2001 through December 5, 2017
| Study group | Role | What they receive |
|---|---|---|
| Prospective population | Experimental | Not described Receives: Diagnostic Test: PET scan |
| Retrospective population | Experimental | Not described Receives: Other: Retrospective data analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
image quality
assessed by blinded readers
Measured: through study completion, on average 2-5 years
artifacts
assessed by blinded readers
Measured: through study completion, on average 2-5 years
lesion detectability
assessed by blinded readers
Measured: through study completion, on average 2-5 years
image noise
assessed region of interest over target tissue and background
Measured: through study completion, on average 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start2 Jan 2015
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PET ImagingStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael V Knopp MD PhD, University of Cincinnati
- Investigators
- Michael V Knopp, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490812
- Sponsor's protocol ID
- RP0689/2013H0280
- Status last verified
- Jan 2024
- First submitted
- 22 Feb 2018
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Investigational Positron Emission Tomography and Post-Processing Procedures Performed as Add-ons to Standard of Care Imaging
- ClinicalTrials.gov ID
- NCT03490812
- Acronym / sponsor ID
- RP0689/2013H0280
- Conditions
- PET Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Apr 2018 (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 goals of this study are to (1) develop and refine PET post-processing acquisition procedures, (2) generate preliminary and comparative imaging data for potential clinical trials, and (3) retrospectively evaluate standard of care PET imaging acquisitions by comparison with investigational PET imaging acquisitions.
Detailed description
The prospective portion of study will utilize investigational PET acquisitions in addition to standard of care PET imaging to develop and optimize PET acquisition post-processing techniques as well as to generate preliminary and comparative data for potential clinical trials. These post-processing techniques include but are not limited to visual inspection of lesions, normal tissue, sentinel nodes and imaging artifacts, semi-quantitative analysis including the use of rating schemes, and using various published methods for image post-processing. The PET methodologies we plan to use as part of this study will allow us to obtain morphological, functional and molecular information. Patients receiving a standard of care PET will be asked by study personnel if they are interested in undergoing additional investigational acquisitions before or after their standard of care imaging. If the patient agrees, he/she will remain on the same PET scanner for up to an additional 30 minutes while more images are obtained. Each patient will be imaged for no longer than 2 hours (standard of care imaging and additional investigational imaging). A routine clinical report will be generated for the clinically indicated PET by a nuclear medicine physician. Once this routine clinical PET scan is dictated and finalized, a study team member will obtain the report via IHIS and manually remove all identifiers. This report is being obtained for comparative purposes. All the data being compared will be coded using a unique study number. The retrospective portion of this study will involve the review of pre-existing data from January 1, 2001 through December 5, 2017. The data to be reviewed/analyzed includes PET imaging data that has been previously collected in the course of standard clinical care. The PET imaging acquisitions obtained from the retrospective review will be utilized as a comparison to the investigational images obtained during the prospective portion of this study. The criteria that will be utilized to determine how the retrospective data will be utilized includes the following parameters: type of imaging study, diagnosis, age in decades, gender, and availability of data in the imaging archive.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective population | Experimental | Diagnostic Test: PET scan |
| Retrospective population | Experimental | Other: Retrospective data analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female volunteers greater than or equal to 18 years of age
- Patients receiving a standard of care PET scan at OSU
- Male and female patients greater than or equal to 18 years of age
- Patients who have previously received a standard of care PET scan at OSU
Key exclusion criteria (5 listed)
- Participants who are pregnant or lactating
- Prisoners
- Subjects incapable of giving informed written consent
- None
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 |
|---|---|---|
| PET scanInvestigational PET scan as add-on to standard-of-care scan | Diagnostic test | Prospective population |
| Retrospective data analysisReview of pre-existing data from January 1, 2001 through December 5, 2017 | Other | Retrospective population |
Primary outcome
image quality
Time frame: through study completion, on average 2-5 years
assessed by blinded readers
artifacts
Time frame: through study completion, on average 2-5 years
assessed by blinded readers
lesion detectability
Time frame: through study completion, on average 2-5 years
assessed by blinded readers
image noise
Time frame: through study completion, on average 2-5 years
assessed region of interest over target tissue and background
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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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.
Michael V Knopp, MD, PhD principal investigator
Ohio State 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 PET scan and Retrospective data analysis in people with PET Imaging, run by University of Cincinnati at 1 site in United States.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. 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 United States. 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?
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?
image quality (time frame: through study completion, on average 2-5 years). The study lists 4 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 18 Jan 2024.