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Not yet recruiting NCT07725237

SPECT/CT Prospective Double-Scanning Study

— Observational SPECT-CT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: StarGuide GX SPECT/CT Scan.
Who it may be relevant to
Registry conditions: SPECT-CT. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Demonstration of the StarGuide GX SPECT/CT System

Overview

The goal of this study is to collect image data for StarGuide GX SPECT/CT System in a clinical setting. The StarGuide GX scan will be compared to the participant's clinically indicated SPECT/CT scanner. Participants will be adult patients scheduled to undergo a clinically indicated SPECT/CT.

Interventions

  • Device StarGuide GX SPECT/CT Scan
    Participants will undergo two SPECT/CT scans and will be randomized to determine whether imaging with the StarGuide GX scanner or the commercially released reference scanner is performed first. The second scan will begin within one hour of completion of the first scan. No additional tracer will be administered prior to the second imaging session, as both scans will utilize the initially administered dose. Following completion of both scans, participants will be asked to complete a brief question

Primary outcome measures

  • Number of StarGuide GX Data Files Collected [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (2)
  • Number of reference data files [Time frame: Through study completion, an average of 1 year]
  • Number of Participant Questionnaires Collected [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Adult, who is at least 18 years of age, on day of consent.
  • Must have a clinical indicated SPECT/CT exam scheduled according to current clinical practice standards; AND
  • Able and willing to provide informed consent for participation in this study.

Exclusion criteria

  • Who, per the site's SOPs, has any condition that would prevent the clinically indicated SPECT/CT from proceeding (i.e., pregnancy, breastfeeding, renal impairment, 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 participant;
  • Unwilling to have GEHC personnel present during scans; OR
  • Unable to tolerate the exam.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Israel · 1 center
  • Rambam Health Care Campus — Haifa

Identifiers

NCT: NCT07725237 · SA-000219

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗