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Standard PET/CT vs. Digital PET/CT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03081767
Recruitment Status : Recruiting
First Posted : March 16, 2017
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

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

Condition or disease Intervention/treatment Phase
Cancer Diagnostic Test: Digital PET/CT scan Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Standard PET/CT vs. Digital PET/CT
Actual Study Start Date : March 29, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Arm Intervention/treatment
Patients undergoing digital PET/CT
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
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.




Primary Outcome Measures :
  1. Diagnostic image quality [ Time Frame: 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081767


Contacts
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Contact: Risa Jiron 6507361598 rjiron@stanford.edu
Contact: Mahima Goel 6507230371 mahimag@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Risa Jiron    650-736-1598    rjiron@stanford.edu   
Contact: Mahima Goel    6507230371    mahimag@stanford.edu   
Principal Investigator: Andrei Iagaru, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Andrei Iagaru, MD Stanford University

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Responsible Party: Andrei Iagaru, Chief of the Division of Nuclear Medicine and Molecular Imaging, Stanford University
ClinicalTrials.gov Identifier: NCT03081767    
Other Study ID Numbers: IRB Protocol: 39329
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrei Iagaru, Stanford University:
PET/CT
digital PET/CT