Standard PET/CT vs. Digital PET/CT

Cancer Clinical Trial

Official title:

Comparison of Standard PET/CT vs. Digital PET/CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081767
• Other study ID #: IRB Protocol: 39329
• Status: Completed
• Phase: N/A
• Start date: March 29, 2017
• Est. completion date: April 1, 2021

Study information

• Verified date: March 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Diagnostic Test:
• Digital PET/CT scan
The Division of Nuclear Medicine and Molecular Imaging at Stanford has installed the first ever GE-made digital PET/CT scanner worldwide. The investigators wish to determine if the digital PET/CT scanner offers equivalent image quality as the standard PET/CT scanner.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Baratto L, Toriihara A, Hatami N, Aparici CM, Davidzon G, Levin CS, Iagaru A. Results of a Prospective Trial to Compare (68)Ga-DOTA-TATE with SiPM-Based PET/CT vs. Conventional PET/CT in Patients with Neuroendocrine Tumors. Diagnostics (Basel). 2021 May 3 — View Citation

Duan H, Baratto L, Hatami N, Liang T, Mari Aparici C, Davidzon GA, Iagaru A. (68)Ga-PSMA11 PET/CT for biochemically recurrent prostate cancer: Influence of dual-time and PMT- vs SiPM-based detectors. Transl Oncol. 2022 Jan;15(1):101293. doi: 10.1016/j.tra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Image Quality	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	an expected average of 3 hours