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Trial Title:
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
Condition:
Cancer
Conditions: Keywords:
Magnifying PET
virtual-pinhole PET
cancer
FDG PET/CT
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Augmented Whole-body Scanning via Magnifying PET
Description:
-Added at the end of the SOC PET/CT scan. Will take approximately 3-5 minutes longer.
Arm group label:
Augmented Whole-body Scanning via Magnifying PET (AWSM-PET)
Other name:
AWSM-PET
Intervention type:
Device
Intervention name:
PET/CT
Description:
-Standard of care
Arm group label:
Augmented Whole-body Scanning via Magnifying PET (AWSM-PET)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult patient 18 years of age or older
- 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:
- For FDG PET/CT only: Patients who have poorly controlled diabetes (fasting blood
glucose > 200 mg/dL obtained directly prior to FDG administration for PET/CT scan)
- Patients whose weight is over 250 lbs or whose body habitus prohibits the AWSM-PET
insert device from being placed at the end of the imaging field of view
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yuan-Chuan Tai, Ph.D.
Phone:
314-362-8429
Email:
taiy@wustl.edu
Investigator:
Last name:
Yuan-Chuan Tai, Ph.D.
Email:
Principal Investigator
Investigator:
Last name:
Farrokh Dehdashti, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Amin Jahromi, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Matthew Powell, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Bryan Meyers, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Varun Puri, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Richard Laforest, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Ningying Wu, M.D., Ph.D.
Email:
Sub-Investigator
Start date:
March 6, 2024
Completion date:
May 31, 2027
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05513027
http://www.siteman.wustl.edu
