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NCT05513027 · ClinicalTrials.gov registry record · NA
Augmented Whole-body Scanning Via Magnifying PET/CT (AWSM-PET/CT) Techniques Abilities to Improve Upon the Diagnostic Accuracy of the Standard-of-care (SOC) PET/CT for Malignant Lesion Detection
A NA study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT05513027: Clinical Trial NA study, sponsored by Washington University School of Medicine.
NCT05513027 is a NA study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05513027, a NA study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
Fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) has been demonstrated to outperform other imaging modalities such as CT and magnetic resonance imaging (MRI) for the detection of metastatic cancers. Therefore, it is currently used for cancer staging, re-staging, and for monitoring response to therapy for many types of cancers. Major advances in PET imaging came to the field in 2016, 2020, 2021 and 2023 when the FDA approved additional PET imaging agents to expand the role of cancer detection to include prostate and neuroendocrine cancers. Despite its wide use and success, the diagnostic accuracy of PET/CT is suboptimal for lesions that are significantly smaller than 1 cm due primarily to limitations on image resolution and system sensitivity. The investigators have developed an Augmented Whole-body Scanning via Magnifying PET (AWSM-PET) technology that can improve the image resolution and system sensitivity of current and future PET/CT scanners. This study will evaluate preliminarily whether the AWSM-PET/CT technology can provide additional high-resolution PET/CT images displayed concurrently with the standard of care PET/CT images to improve overall accuracy in depicting malignant lesions in cancer patients.
Primary Outcome
The true presence and absence of malignancy in each lesion (binary reference standard), will be obtained through multiple sources including pathology report of surgically removed or biopsied tissues, imaging follow-up and clinical follow-up. The separately reconstructed SOC PET/CT and the AWSM PET/CT imaging reading of each lesion will be graded by two raters, separately, via a five-point scale: 1 = definitely benign; 2 = probably benign; 3 = equivocal; 4 = probably malignant; and 5 = definitely
Interventions
- DEVICE PET/CT
- DEVICE Augmented Whole-body Scanning via Magnifying PET
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2024-03-06 |
| Est. Completion | 2026-03-17 |
| Phase | NA |
Why NCT05513027 stopped before completion
NCT05513027 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which PET/CT is the first listed.
NCT05513027 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05513027 about?
NCT05513027 is a clinical study titled "Augmented Whole-body Scanning Via Magnifying PET/CT (AWSM-PET/CT) Techniques Abilities to Improve Upon the Diagnostic Accuracy of the Standard-of-care (SOC) PET/CT for Malignant Lesion Detection". Fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) has been demonstrated to outperform other imaging modalities such as CT and magnetic resonance imaging (MRI) for the detection of metastatic cancers. Therefore, it is currently used for cancer staging, re-staging, a...
What is the current status of trial NCT05513027?
This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2024-03-06. Estimated completion is 2026-03-17.
What interventions are being tested in trial NCT05513027?
The interventions under investigation include: PET/CT (DEVICE), Augmented Whole-body Scanning via Magnifying PET (DEVICE).
Who is sponsoring clinical trial NCT05513027?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05513027's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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