Diagnostic Accuracy of the Augmented Whole-body Scanning Via Magnifying PET (AWSM-PET) Technique Versus the Standard-of-care (SOC) FDG PET/CT for Malignant Lesion Detection

Study Overview
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Brief Summary
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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. Despite its wide use and success, the diagnostic accuracy of FDG-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 technology can improve the diagnostic accuracy of FDG PET/CT for the detection of malignant lesions in cancer patients.

Official Title
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A Prospective Study of the Diagnostic Accuracy of the Augmented Whole-body Scanning Via Magnifying PET (AWSM-PET) Technique Versus the Standard-of-care (SOC) FDG PET/CT for Malignant Lesion Detection

Conditions
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Cancer

Intervention / Treatment
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* Device: Augmented Whole-body Scanning via Magnifying PET
* Device: FDG-PET/CT
* Drug: 18F- fluorodeoxyglucose


Participation Criteria
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Eligibility Criteria
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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) FDG-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 FDG-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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented Whole-body Scanning via Magnifying PET (AWSM-PET)<br>All enrolled subjects will undergo SOC FDG-PET/CT scan with an AWSM PET device positioned at the far end of the Biograph Vision PET/CT scanner. The patient will receive 10-20 mCi FDG injection according to the SOC FDG-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<br>* -Added at the end of the SOC FDG-PET/CT scan. Will take approximately 3-5 minutes longer.<br>* Other names: AWSM-PET;Device: FDG-PET/CT<br>* -Standard of care<br>Drug: 18F- fluorodeoxyglucose<br>* -Standard of care given with FDG-PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 FDG-PET/CT and the AWSM PET 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 FDG-PET/CT | SOC FDG-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 | • AWSM PET 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess whether a nuclear medicine physician's confidence is altered by the AWSM-PET technology | Evaluate whether the indefinite ratings (score of 2-4) for SOC FDG PET/CT is changed to a definitive category (categories 1 and 5) by the AWSM-PET. A study specific review outside of the SOC FDG-PET/CT report will be conducted by 2 certified nuclear medicine physicians. Study specific review of the SOC FDG-PET/CT will occur within 21 days of scan completion this will be followed 30-45 days later by study specific review of the AWSM-PET scan by the same physician. The 2nd study specific physician will review scans in the opposite order following the same time line. After half of the subjects' scans are reviewed, the order of review will be reversed for both physicians to avoid any potential bias. 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 | Through 45 days after completion of scan | 
| Image quality score | Image quality score of the SOC FDG PET/CT and the AWSM-PET images will be compared to confirm that the simultaneously acquired scans are both of diagnostic quality.Within 21 days of scan completion, one of the engaged nuclear medicine physicians will be assigned to review the SOC FDG-PET/CT scan while the other physician will review the AWSM PET scan. 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. Study specific review of the SOC FDG-PET/CT will occur within 21 days of scan completion this will be followed 30-45 days later by study specific review of the AWSM-PET scan by the same physician. The 2nd study specific physician will review scans in the opposite order following the same time line. After half of the subjects' scans are reviewed, the order of review will be reversed for both physicians to avoid any potential bias. | 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 | The overall comfort during the last 3-5 minutes of the scan (added due to the AWSM-PET technology) as compared to the first 15-20 minutes of the scan (for a typical SOC FDG-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. | Through completion of scan (Day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnifying PET, virtual-pinhole PET, cancer, FDG PET/CT