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NCT03320564 · ClinicalTrials.gov registry record · NA
Infiltration Effect on SUV
A NA study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT03320564 is a NA study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 2 participants.
The verdict
NCT03320564, a NA study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
A widely used semi-quantitative parameter to assess tumor status is the standardized uptake value (SUV). SUV estimation accuracy can be impacted by many variables. Today there still exists a significant amount of variability in PET/CT results in test and re-test studies. This variability can be introduced by instrumentation and subject-specific factors. Variability reduces image quality and increases the required changes in tumor quantification to reflect real tumor response or progression. PET/CT scanning process requires that the entire net injected dose of radiolabeled tracer is administered intravenously as a bolus. The quality and quantification of a PET/CT image is highly dependent on the uptake of radiolabeled tracer. Boellaard et al. have indicated infiltrations could potentially underestimate SUV measurements by as much as 50%. Infiltrations and obstructions are not uncommon. Recent studies using a novel QA/QC tool (LaraTM System) for the radiotracer injection process revealed that current means to detect infiltration do not completely identify all infiltrations/obstructions. Since infiltrations may not be visible in the standard field of view (FOV) and since the impact of a peripheral circulatory obstruction may not be visible even if an injection site is in the FOV, it is possible for reading and treating physicians to be unaware that a patient's image and quantification has been impacted. Additionally, when current means do detect an infiltration, they under-represent the severity because they are not capturing that infiltrations often resolve during the uptake period. As a result, infiltrations or obstructions may cause SUV inaccuracy and could adversely impact staging and tumor assessments. The purpose of this study will be to characterize the impact of moderate or greater infiltrations on standardized uptake values. Patients experiencing a moderate or greater infiltration on a routine clinical PET scan will be invited to return for a repeat scan wi
Interventions
- DIAGNOSTIC_TEST F-18 FDG PET
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2018-08-27 |
| Est. Completion | 2019-02-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03320564
The ClinicalTrials.gov registry entry for NCT03320564 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which F-18 FDG PET is the first listed.
NCT03320564 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03320564 about?
NCT03320564 is a clinical study titled "Infiltration Effect on SUV". A widely used semi-quantitative parameter to assess tumor status is the standardized uptake value (SUV). SUV estimation accuracy can be impacted by many variables. Today there still exists a significant amount of variability in PET/CT results in test and re-test studies. This variability can be intr...
What is the current status of trial NCT03320564?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2018-08-27. Estimated completion is 2019-02-13.
What interventions are being tested in trial NCT03320564?
The interventions under investigation include: F-18 FDG PET (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03320564?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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