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Recruiting

NCT Number: NCT07661706

Data Collection of New Spectral CT Imaging Method

The purpose of the study is to collect data to evaluate utility of a next generation spectral CT system in a clinical setting.

Recruiting

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Key information

Conditions

Computed Tomography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location status: Recruiting

Location contact

Monica Hosler

CONTACT

[email protected]

484-658-4567

Pallav N Shah, MD

PRINCIPAL_INVESTIGATOR

About this study

Data collected in this study includes an assessment of image quality parameters to evaluate the product. This data and analysis will help support regulatory submissions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Who are ≥18 years of age;
  • Able to sign and date the informed consent form; AND,
  • Who have in the past 90 days or will in the future 30 days of the investigational scan undergo a clinically indicated CT exam within the St. Luke's University Hospital Network of the neck, chest, abdomen, pelvis, or extremities.

Exclusion criteria

  • Who are pregnant or lactating;
  • Who were previously enrolled in this study;
  • For planned contrast-enhanced investigational CT exams, anyone with known or suspected allergy to iodinated contrast agents;
  • For planned contrast-enhanced investigational CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
  • 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 or constitute a health hazard for the subject; OR,
  • Who are unwilling to have GEHC personnel present for the CT exam.

Treatment and study plan

Research CT

Device

Participants will undergo a research CT on an investigational Spectral CT Imaging scanner which will be matched to their prior or scheduled SOC CT. Scans will be matched on anatomy, radiation dose, and contrast administration.

Primary outcomes

  1. Evaluable Raw Research Scans

    Time frame: Through study completion, an average of 1 year

    Number of participants who research scan is deemed evaluable (i.e., no issues with participant motion or contrast administration/timing)

Secondary outcomes

  1. Safety Assessment

    Time frame: Through study completion, an average of 1 year

    Number of Adverse Events and/or Serious Adverse Events reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Challman, MPH, CCRP

CONTACT

[email protected]

18582213007

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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