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Radiopharmaceutical

AWSM-PET Technique vs Standard PET/CT for Cancer Detection

N/A

Recruiting

Led By Yuan-Chuan Tai, Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 45 days after completion of scan

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a new PET/CT technology can improve the accuracy of detecting small malignant lesions in cancer patients.

Who is the study for?

This trial is for adults over 18 with suspected or confirmed carcinoma who need a PET/CT scan. They must understand and consent to the study, possibly undergo biopsy or surgery before other treatments, and be able to lie still for about 30 minutes during imaging. Women of childbearing age need a negative pregnancy test.

What is being tested?

The AWSM-PET technique's ability to detect malignant lesions in cancer patients is being compared against the standard FDG PET/CT scans. The goal is to see if AWSM-PET can provide better image resolution and sensitivity, especially for very small lesions.

What are the potential side effects?

While not explicitly listed, side effects may include discomfort from lying still during imaging and potential risks associated with exposure to radiation from the PET/CT scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 45 days after completion of scan

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 45 days after completion of scan

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 45 days after completion of scan for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Image reading of each lesion on AWSM-PET/CT

Image reading of each lesion on SOC PET/CT

Malignant Neoplasms

Secondary study objectives

Image quality score

To assess whether a nuclear medicine physician's confidence is altered by the AWSM-PET/CT technology

Tolerability as measured by overall comfort of the scan

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Augmented Whole-body Scanning via Magnifying PET (AWSM-PET)Experimental Treatment2 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET/CT

2022

Completed Phase 3

~1300

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