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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- True presence and absence of malignancy in each lesion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Augmented Whole-body Scanning via Magnifying PET (AWSM-PET)
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).
干预措施: Augmented Whole-body Scanning via Magnifying PET (Device)
Augmented Whole-body Scanning via Magnifying PET (AWSM-PET)
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).
干预措施: PET/CT (Device)
结局指标
主要结局
True presence and absence of malignancy in each lesion
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))