CancerNCT05513027
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 study testing Augmented Whole-body Scanning via Magnifying PET and PET/CT in people with Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Augmented Whole-body Scanning via Magnifying PET and PET/CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2024to 17 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 or whose body habitus prohibits the AWSM-PET insert device from being placed at the end of the imaging field of view
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Prospective Study of the 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, 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.
- Conditions
- Cancer
- Being tested
- Augmented Whole-body Scanning via Magnifying PET, PET/CT
- Keywords
- Magnifying PET, virtual-pinhole PET, cancer, FDG PET/CT
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Whole-body Scanning via Magnifying PETDevice
Also called AWSM-PET
-Added at the end of the SOC PET/CT scan. Will take approximately 3-5 minutes longer.
PET/CTDevice
-Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Augmented Whole-body Scanning via Magnifying PET (AWSM-PET) | Experimental | 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). Receives: Device: Augmented Whole-body Scanning via Magnifying PET; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
True presence and absence of malignancy in each lesion
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 malignant. For patients who proceed to surgery or biopsy and histopathologic results are available, the two sets of images with be compared and correlated with the histopathologic results. Each scan will be graded in concordance with the reference standard as true positive, true negative, false positive or false negative. If there is a question about lesion location corresponding to the same area on imaging and pathology additional resources such as the operative report will be utilized.
Measured: Through 9 months after completion of scan
Image reading of each lesion on SOC PET/CT
SOC PET/CT image 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 malignant.
Measured: Through 45 days after completion of scan
Image reading of each lesion on AWSM-PET/CT
AWSM PET/CT image 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 malignant.
Measured: Through 45 days after completion of scan
Secondary outcomes (4)
To assess whether a nuclear medicine physician's confidence is altered by the AWSM-PET/CT technology
Evaluate whether the indefinite ratings (score of 2-4) for SOC PET/CT is changed to a definitive category (categories 1 and 5) by the AWSM-PET/CT. A study specific review outside of the SOC PET/CT report will be conducted by 2 certified nuclear medicine physicians in batch analyses. The batch analyeses will occur in groups of 3 participants and will be completed within 21 days after the 3rd partcipant's AWSM-PET/CT has been reconstructed. Both physicians will review the SOC PET/CT followed by review of the SOC PET/CT with the AWSM-PET/CT as supplemental imaging. Up to 4 lesions will be recorded and graded according to a five-point scale: 1 = definitely benign; 2 = probably benign; 3 = equivocal; 4 = probably malignant; and 5 = definitely malignant
Measured: Through 45 days after completion of scan
Image quality score
Image quality score of the SOC PET/CT and the AWSM-PET/CT images will be compared to confirm that the simultaneously acquired scans are both of diagnostic quality. A study specific review outside of the SOC PET/CT report will be conducted by 2 certified nuclear medicine physicians in batch analyses. The batch analyeses will occur in groups of 3 participants and will be completed within 21 days after the 3rd partcipant's AWSM-PET/CT has been reconstructed. Both physicians will review the SOC PET/CT followed by review of the SOC PET/CT with the AWSM-PET/CT as supplemental imaging.
Overall quality of the assigned scan will be evaluated and graded on a 4 point scale: 1= Poor uninterpretable; 2= Poor acceptable for review; 3= Fair; 4= Good/Diagnostic.
Measured: Through 45 days after completion of scan
Tolerability as measured by number of patients who find the scan intolerable and have to terminate the study
Measured: Through completion of study (estimated to be 30 months)
Tolerability as measured by overall comfort of the scan
The overall comfort during the last 3-5 minutes of the scan (added due to the AWSM-PET/CT technology) as compared to the first 15-20 minutes of the scan (for a typical SOC PET/CT). This will be reported via a five-point scale: 1 = extremely uncomfortable, unbearable; 2 = somewhat uncomfortable but bearable; 3 = neutral, neither comfortable nor uncomfortable; 4 = somewhat comfortable; 5 = very comfortable and relaxing.
Measured: Through completion of scan (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start6 Mar 2024
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yuan-Chuan Tai, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513027
- Sponsor's protocol ID
- 202207154
- Other IDs
- 1R01CA233912
- Status last verified
- May 2026
- First submitted
- 18 Aug 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual patient data that underlie the results reported including text, tables, figures, images and appendices. Study protocol, blank consent, imaging data in DICOM format
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the 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
- ClinicalTrials.gov ID
- NCT05513027
- Acronym / sponsor ID
- 202207154
- Conditions
- Cancer
- Keywords
- Magnifying PET, virtual-pinhole PET, cancer, FDG PET/CT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmented Whole-body Scanning via Magnifying PET (AWSM-PET) | Experimental | Device: Augmented Whole-body Scanning via Magnifying PET, Device: PET/CTAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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 or whose body habitus prohibits the AWSM-PET insert device from being placed at the end of the imaging field of view
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Whole-body Scanning via Magnifying PETAlso: AWSM-PET-Added at the end of the SOC PET/CT scan. Will take approximately 3-5 minutes longer. | Device | Augmented Whole-body Scanning via Magnifying PET (AWSM-PET) |
| PET/CT-Standard of care | Device | Augmented Whole-body Scanning via Magnifying PET (AWSM-PET) |
Primary outcome
True presence and absence of malignancy in each lesion
Time frame: Through 9 months after completion of scan
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 malignant. For patients who proceed to surgery or biopsy and histopathologic results are available, the two sets of images with be compared and correlated with the histopathologic results. Each scan will be graded in concordance with the reference standard as true positive, true negative, false positive or false negative. If there is a question about lesion location corresponding to the same area on imaging and pathology additional resources such as the operative report will be utilized.
Image reading of each lesion on SOC PET/CT
Time frame: Through 45 days after completion of scan
SOC PET/CT image 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 malignant.
Image reading of each lesion on AWSM-PET/CT
Time frame: Through 45 days after completion of scan
AWSM PET/CT image 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 malignant.
4 secondary outcomes
To assess whether a nuclear medicine physician's confidence is altered by the AWSM-PET/CT technology
Time frame: Through 45 days after completion of scan
Image quality score
Time frame: Through 45 days after completion of scan
Tolerability as measured by number of patients who find the scan intolerable and have to terminate the study
Time frame: Through completion of study (estimated to be 30 months)
Tolerability as measured by overall comfort of the scan
Time frame: Through completion of scan (Day 1)
Results and safety
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified individual patient data that underlie the results reported including text, tables, figures, images and appendices. Study protocol, blank consent, imaging data in DICOM format
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan-Chuan Tai, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Whole-body Scanning via Magnifying PET and PET/CT in people with Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
True presence and absence of malignancy in each lesion (time frame: Through 9 months after completion of scan). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.