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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
11
-Added at the end of the SOC PET/CT scan. Will take approximately 3-5 minutes longer.
-Standard of care
Washington University School of Medicine
St Louis, Missouri, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Through 45 days after completion of scan
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
Time frame: 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.
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
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.
Time frame: Through completion of scan (Day 1)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.