Standard PET/CT vs. Digital PET/CT

NCT03081767 | Completed Results DMC FDA Device

• 1 other identifier: IRB Protocol: 39329
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Keywords

PET/CT; digital PET/CT

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients undergoing digital PET/CT

OTHER

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.

Diagnostic Test: Digital PET/CT scan

Interventions

Digital PET/CT scan DIAGNOSTIC_TEST

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.

Patients undergoing digital PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patient is pregnant or nursing

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• Duan H, Baratto L, Hatami N, Liang T, Mari Aparici C, Davidzon GA, Iagaru A. 68Ga-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.tranon.2021.101293. Epub 2021 Nov 22.

  PMID: 34823095 RESULT

• Baratto L, Toriihara A, Hatami N, Aparici CM, Davidzon G, Levin CS, Iagaru A. Results of a Prospective Trial to Compare 68Ga-DOTA-TATE with SiPM-Based PET/CT vs. Conventional PET/CT in Patients with Neuroendocrine Tumors. Diagnostics (Basel). 2021 May 30;11(6):992. doi: 10.3390/diagnostics11060992.

  PMID: 34070751 RESULT

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Andrei Iagaru
• Organization: Stanford University

aiagaru@stanford.edu

6507254711

Study Officials

• Andrei Iagaru, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Division of Nuclear Medicine and Molecular Imaging

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 16, 2017
• Study Start: March 29, 2017
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 12, 2022
• Results First Posted: April 12, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)