Standard PET/CT vs. Digital PET/CT

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Diagnostic Test: Digital PET/CT scan

• Registration Number: NCT03081767
• Lead Sponsor: Stanford University

Brief Summary

The investigators wish to determine if standard and digital PET/CT scanners provide equivalent results for disease detection and diagnosis.

Detailed Description

There will be a single injection of the PET radiopharmaceutical followed by a standard PET/CT scan and immediately after by the digital PET/CT scan, or vice versa. The investigators wish to determine if image quality is equivalent with the digital PET/CT scanner.

Study Timeline

• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-16
• Study Start: 2017-03-29
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2022-03
• Results First Submitted: 2022-03-18
• Results First Submitted QC: 2022-03-18
• Last Update Submitted: 2022-03-18
• Results First Posted: 2022-04-12
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

• Patient is ≥ 18 years old at the time of the scan
• Patient provides written informed consent
• Patient is referred for standard (F18 FDG; F18 NaF; Ga68 DOTATATE) or research (68Ga PSMA or 68Ga RM2) PET/CT
• Patient is capable of complying with study procedures
• Patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both PET/CT)

Exclusion Criteria

• Patient is pregnant or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing digital PET/CT	Digital PET/CT scan	Single arm prospective study of paired imaging studies. Patients who are referred to Nuclear Medicine and are scheduled to undergo imaging on the standard PET/CT will also have imaging performed on the digital PET/CT.

Primary Outcome Measures

Name	Time	Method
Diagnostic Image Quality	an expected average of 3 hours	Diagnostic image quality will be determined using a 5-point Likert Scale that reads: 5 - Diagnostic: Excellent diagnostic image quality; 4 - Diagnostic: Good diagnostic image quality; 3 - Diagnostic: Acceptable diagnostic image quality; 2 - Sub-optimal diagnostic: image quality with limited additional clinical information; 1 - Non-diagnostic: non-diagnostic image quality

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States