PET/CT ImagingNCT03519659
Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT
A study testing PET/CT scan with 13 mCi radiation dose, PET/CT scan with 5 mCi radiation dose and PET/CT scan with 2.5 mCi radiation dose in people with PET/CT Imaging, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to assess new low radiation dose techniques for clinical PET/CT scans through intra-individual comparison between a clinical, standard dose scan and a low-dose scan, completed within one week of each other. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PET/CT Imaging
- What is being tested?
- PET/CT scan with 13 mCi radiation dose, PET/CT scan with 5 mCi radiation dose and PET/CT scan with 2.5 mCi radiation dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 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 patients greater than or equal to 18 years of age
- Patients scheduled for a standard of care PET/CT scan
- For female patients of child-bearing potential, the OSUWMC requirements for receiving the standard of care PET imaging agent and CT examination needs to be met
Who cannot join
- Participants who are pregnant or lactating
- Prisoners
- Participants incapable of giving informed consent
- Patients unable to lie flat on the scanner for extended periods of time
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 purpose of this study is to assess new low radiation dose techniques for clinical PET/CT scans through intra-individual comparison between a clinical, standard dose scan and a low-dose scan, completed within one week of each other.
Read the detailed description
Positron Emission Tomography/Computed Tomography (PET/CT) imaging using 18F-FDG is an important, commonly used cancer, neuroscience and cardio-vascular imaging methodology to detect disease and to monitor therapeutic interventions. While considerable technological progress of PET/CT systems has occurred over the last decade, we have not re-evaluated the ability to potentially reduce the radiation burden of the used PET imaging pharmaceutical (FDG).
This early phase trial intends to accomplish the following:
- to validate that the radiation dose burden from the PET imaging pharmaceutical (FDG) can be reduced by more than 50% from the current standard of clinical care (SOC) level without affecting the diagnostic ability;
- to confirm that a low dose approach will be feasible for response assessment;
- to validate that the difference in FDG uptake between imaging 60 min +/- 10 min post injection and 75 min +/- 10 min post injection is independent/equivalent of the injected FDG dose
- to validate a simulation methodology to streamline future dose finding studies for PET imaging pharmaceuticals.
- Conditions
- PET/CT Imaging
- Being tested
- PET/CT scan with 13 mCi radiation dose, PET/CT scan with 5 mCi radiation dose, PET/CT scan with 2.5 mCi radiation dose, PET/CT Scan with 6.5 mCi radiation dose, PET/CT Scan with not yet determined radiation dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT scan with 13 mCi radiation doseDiagnostic test
13 mCi 18F-FDG dose
PET/CT scan with 5 mCi radiation doseDiagnostic test
5 mCi 18F-FDG dose
PET/CT scan with 2.5 mCi radiation doseDiagnostic test
2.5 mCi 18F-FDG dose
PET/CT Scan with 6.5 mCi radiation doseDiagnostic test
6.5 mCi 18F-FDG dose
PET/CT Scan with not yet determined radiation doseDiagnostic test
We plan for the possibility that one of the three-Sub-Studies (A-B) would not demonstrate equivalency, and we would then perform a modified protocol in which the SOC dosing is compared to a lower and higher dose than originally tested.
| Study group | Role | What they receive |
|---|---|---|
| Sub-Study A | Experimental | Patients receive PET/CT scan on Gemini Astonish PET/CT Receives: Diagnostic Test: PET/CT scan with 13 mCi radiation dose; Diagnostic Test: PET/CT scan with 5 mCi radiation dose |
| Sub-Study B | Experimental | Patients receive PET/CT scan on Biograph mCT Receives: Diagnostic Test: PET/CT scan with 13 mCi radiation dose; Diagnostic Test: PET/CT scan with 5 mCi radiation dose |
| Sub-Study C | Experimental | Patients receive PET/CT scan on Discovery PET/CT Receives: Diagnostic Test: PET/CT scan with 13 mCi radiation dose; Diagnostic Test: PET/CT scan with 5 mCi radiation dose |
| Sub-Study D | Experimental | Patients receive PET/CT scan on Vereos 128 digital PET/CT Receives: Diagnostic Test: PET/CT scan with 13 mCi radiation dose; Diagnostic Test: PET/CT scan with 5 mCi radiation dose |
| Sub-Study E | Experimental | Patients receive lower radiation dose on Vereos 128 digital PET/CT Receives: Diagnostic Test: PET/CT scan with 2.5 mCi radiation dose; Diagnostic Test: PET/CT Scan with 6.5 mCi radiation dose |
| Sub-Study F | Experimental | Patients receive PET/SCAN using system that did not show equivalence in Sub-Study A-C Receives: Diagnostic Test: PET/CT scan with 13 mCi radiation dose; Diagnostic Test: PET/CT Scan with not yet determined radiation dose |
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
Secondary outcomes (3)
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 by blinded readers
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 posted9 May 2018
- Study start21 Jul 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/CT 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Ohio Third Frontier
- 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
- NCT03519659
- Sponsor's protocol ID
- RP0308/2014H0437
- Other IDs
- R01CA195513
- 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
- Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT
- ClinicalTrials.gov ID
- NCT03519659
- Acronym / sponsor ID
- RP0308/2014H0437
- Conditions
- PET/CT Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Ohio Third Frontier
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 May 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 purpose of this study is to assess new low radiation dose techniques for clinical PET/CT scans through intra-individual comparison between a clinical, standard dose scan and a low-dose scan, completed within one week of each other.
Detailed description
Positron Emission Tomography/Computed Tomography (PET/CT) imaging using 18F-FDG is an important, commonly used cancer, neuroscience and cardio-vascular imaging methodology to detect disease and to monitor therapeutic interventions. While considerable technological progress of PET/CT systems has occurred over the last decade, we have not re-evaluated the ability to potentially reduce the radiation burden of the used PET imaging pharmaceutical (FDG).
This early phase trial intends to accomplish the following:
- to validate that the radiation dose burden from the PET imaging pharmaceutical (FDG) can be reduced by more than 50% from the current standard of clinical care (SOC) level without affecting the diagnostic ability;
- to confirm that a low dose approach will be feasible for response assessment;
- to validate that the difference in FDG uptake between imaging 60 min +/- 10 min post injection and 75 min +/- 10 min post injection is independent/equivalent of the injected FDG dose
- to validate a simulation methodology to streamline future dose finding studies for PET imaging pharmaceuticals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sub-Study A | Experimental | Diagnostic Test: PET/CT scan with 13 mCi radiation dose, Diagnostic Test: PET/CT scan with 5 mCi radiation dosePatients receive PET/CT scan on Gemini Astonish PET/CT |
| Sub-Study B | Experimental | Diagnostic Test: PET/CT scan with 13 mCi radiation dose, Diagnostic Test: PET/CT scan with 5 mCi radiation dosePatients receive PET/CT scan on Biograph mCT |
| Sub-Study C | Experimental | Diagnostic Test: PET/CT scan with 13 mCi radiation dose, Diagnostic Test: PET/CT scan with 5 mCi radiation dosePatients receive PET/CT scan on Discovery PET/CT |
| Sub-Study D | Experimental | Diagnostic Test: PET/CT scan with 13 mCi radiation dose, Diagnostic Test: PET/CT scan with 5 mCi radiation dosePatients receive PET/CT scan on Vereos 128 digital PET/CT |
| Sub-Study E | Experimental | Diagnostic Test: PET/CT scan with 2.5 mCi radiation dose, Diagnostic Test: PET/CT Scan with 6.5 mCi radiation dosePatients receive lower radiation dose on Vereos 128 digital PET/CT |
| Sub-Study F | Experimental | Diagnostic Test: PET/CT scan with 13 mCi radiation dose, Diagnostic Test: PET/CT Scan with not yet determined radiation dosePatients receive PET/SCAN using system that did not show equivalence in Sub-Study A-C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients greater than or equal to 18 years of age
- Patients scheduled for a standard of care PET/CT scan
- For female patients of child-bearing potential, the OSUWMC requirements for receiving the standard of care PET imaging agent and CT examination needs to be met
Key exclusion criteria (4 listed)
- Participants who are pregnant or lactating
- Prisoners
- Participants incapable of giving informed consent
- Patients unable to lie flat on the scanner for extended periods of time
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/CT scan with 13 mCi radiation dose13 mCi 18F-FDG dose | Diagnostic test | Sub-Study A, Sub-Study B, Sub-Study C, Sub-Study D, Sub-Study F |
| PET/CT scan with 5 mCi radiation dose5 mCi 18F-FDG dose | Diagnostic test | Sub-Study A, Sub-Study B, Sub-Study C, Sub-Study D |
| PET/CT scan with 2.5 mCi radiation dose2.5 mCi 18F-FDG dose | Diagnostic test | Sub-Study E |
| PET/CT Scan with 6.5 mCi radiation dose6.5 mCi 18F-FDG dose | Diagnostic test | Sub-Study E |
| PET/CT Scan with not yet determined radiation doseWe plan for the possibility that one of the three-Sub-Studies (A-B) would not demonstrate equivalency, and we would then perform a modified protocol in which the SOC dosing is compared to a lower and higher dose than originally tested. | Diagnostic test | Sub-Study F |
Primary outcome
Image quality
Time frame: through study completion, on average 2-5 years
assessed by blinded readers
3 secondary outcomes
Artifacts
Time frame: through study completion, on average 2-5 years
Lesion detectability
Time frame: through study completion, on average 2-5 years
Image noise
Time frame: through study completion, on average 2-5 years
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.
Related trials for PET/CT Imaging
RecruitingPhase 1/2
Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome
Cushing s Syndrome
RecruitingPhase 2
The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
Metastic Thyroid Cancer
Active, not recruitingPhase 2
18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
Prostate Neoplasms, Prostatic Cancer
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
Healthy
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/CT scan with 13 mCi radiation dose, PET/CT scan with 5 mCi radiation dose and PET/CT scan with 2.5 mCi radiation dose in people with PET/CT 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 3 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: 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). 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.