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
NCT ID: NCT05513027
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
11 participants
INTERVENTIONAL
2024-03-06
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Augmented Whole-body Scanning via Magnifying PET (AWSM-PET)
All enrolled subjects will undergo SOC PET/CT scan with an AWSM PET device positioned at the far end of the Biograph Vision PET/CT scanner. The patient will receive injection of the PET radiopharmaceutical according to the SOC PET/CT protocol dosing schedule. The entire study will require approximately 2 ½ - 3 hours (from the time patient arrives to the completion of the scan).
Augmented Whole-body Scanning via Magnifying PET
-Added at the end of the SOC PET/CT scan. Will take approximately 3-5 minutes longer.
PET/CT
-Standard of care
Interventions
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Augmented Whole-body Scanning via Magnifying PET
-Added at the end of the SOC PET/CT scan. Will take approximately 3-5 minutes longer.
PET/CT
-Standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with suspected or pathologically confirmed diagnosis of carcinoma scheduled to undergo standard of care (SOC) PET/CT for initial diagnosis, initial staging, or suspected recurrence. Preference is to enroll those subjects who will undergo biopsy or surgical resection prior to other cancer treatment.
* Willing to undergo PET/CT imaging with AWSM-PET.
* Patients of child-bearing potential must have a negative urine pregnancy test on the day of the PET/CT scan. Postmenopausal women who self-report as amenorrheic for at least 12 consecutive months are to be considered not of child-bearing potential.
* Patients must be able to understand and sign an IRB-approved informed consent form that allows access to prior medical records, participation in the study and chart review follow up.
* Patients are able to tolerate up to approximately 30 min of PET imaging.
Exclusion Criteria
* Patients whose weight or whose body habitus prohibits the AWSM-PET insert device from being placed at the end of the imaging field of view
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Yuan-Chuan Tai, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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202207154
Identifier Type: -
Identifier Source: org_study_id
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