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

NCT05513027 | Terminated DMC FDA Device

• 2 other identifiers: 2022071541R01CA233912
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

Magnifying PET; virtual-pinhole PET; cancer; FDG PET/CT

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  Through 45 days after completion of scan

• Image quality score

  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

  Through completion of study (estimated to be 30 months)

• Tolerability as measured by overall comfort of the scan

  Through completion of scan (Day 1)

Study Arms (1)

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).

Device: Augmented Whole-body Scanning via Magnifying PET; Device: PET/CT

Interventions

Augmented Whole-body Scanning via Magnifying PET DEVICE

-Added at the end of the SOC PET/CT scan. Will take approximately 3-5 minutes longer.

Also known as: AWSM-PET

Augmented Whole-body Scanning via Magnifying PET (AWSM-PET)

PET/CT DEVICE

-Standard of care

Augmented Whole-body Scanning via Magnifying PET (AWSM-PET)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Yuan-Chuan Tai, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 23, 2022
• Study Start: March 6, 2024
• Primary Completion: March 17, 2026
• Study Completion: March 17, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: within 6 months of initial publication no planned end date
• Access Criteria: Anyone who can access the data

Locations

US (1)