Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT03519659
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2018-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT
Sponsor:
University of Cincinnati
Organization:
Study Overview
Official Title:
Validating Low FDG Dose PET/CT Compared to Current Standard of Care Dose PET/CT
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA195513 | NIH | None | https://reporter.nih.gov/quic… | View |