Recruiting

Omni 128 cm PET/CT

Sponsor:

GE Healthcare

Code:

NCT07857161

Conditions

PET/CT

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Omni 128cm PET/CT

Study Details

Brief summary:

This study aims to collect clinical image data using the Omni 128 cm PET/CT system and compare image quality and performance with clinically indicated PET/CT examinations. Adult participants undergoing a clinically indicated PET/CT scan will also undergo imaging on the Omni 128 cm PET/CT system for research evaluation purposes.

Conditions

PET/CT

Study ID

NCT07857161

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Must have a clinical indicated PET/CT exam scheduled including (but not limited to) one of the following radiopharmaceutical tracers: Fluorodeoxyglucose (FDG or 18F-FDG), 18F-DCFPyL; 68Ga- PSMA; 68Ga Dotatate; 18F Amyloid (18F- Florbetapir, 18F-Florbetaben, or 18F-Flutemetamol), or Other standard PET tracers;
  • Age ≥ 18 years old at time of consent;
  • Able to provide informed consent; AND,
  • Has the necessary mental capacity to understand instructions and is able to comply with protocol requirements.

Exclusion Criteria:

  • Who, per the site's SOPs, has any condition that would prevent the clinically indicated PET/CT from proceeding (i.e., pregnancy, breastfeeding, renal impairment, elevated blood glucose, etc.);
  • Who were previously enrolled in this study;
  • Who need urgent or emergent care;
  • Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results, constitute a health hazard for the subject;
  • Unwilling to have GEHC personnel present during scans; OR,
  • Unable to tolerate the exam.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Single Group Study

Adult patients scheduled to undergo a clinically indicated PET/CT

Interventions

Omni 128cm PET/CT

Participants will undergo two PET/CT scans. The first scan will be performed on a commercially available PET/CT system as part of standard clinical care, and the second scan will be performed on the investigational Omni 128 cm PET/CT system. The investigational scan will begin within one hour of completion of the standard-of-care scan. No additional radiopharmaceutical tracer will be administered before the second imaging session.

Primary outcome measure

  • Number of Complete PET/CT Device Data Sets Collected [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts and Locations

Central contacts

Erin Terrell, MS

262-449-3363erin.terrell@gehealthcare.com

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Andrea Otte, DPT, CCRC

650-736-4183anotte@stanford.edu

Principal Investigator:

Andrei Iagaru, MD

More Information

Sponsor

GE Healthcare

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

  • PET/CT
  • Clinically indicated
  • Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by GE Healthcare on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.