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

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Aug 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technology called Augmented Whole-body Scanning via Magnifying PET (AWSM-PET) to see if it can help doctors find cancerous lesions more accurately than the standard PET/CT scans currently used. PET/CT scans are important tools for diagnosing and monitoring cancer, but they can sometimes miss smaller tumors. The researchers want to find out if the AWSM-PET technology can produce clearer images that will help in detecting these small malignant lesions in patients suspected of having cancer.

To be eligible for the trial, participants must be adults aged 18 or older with a confirmed or suspected cancer diagnosis who are scheduled for a standard PET/CT scan. They should also be willing to undergo the new AWSM-PET imaging. Patients need to be able to tolerate about 30 minutes of imaging and must meet certain health criteria, such as having controlled blood sugar levels. Participants will receive a PET/CT scan using both the standard method and the new technology, which could offer better detection of cancer. Overall, this trial aims to improve the way cancer is diagnosed, potentially leading to better treatment outcomes for patients.

Gender

ALL

Eligibility criteria

• 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) 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.
• Exclusion Criteria:
• • 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