To Evaluate Transport Safety Between Different Scanning Methods for Patients in the Intensive Care Unit (ICU) (CASA)

March 31, 2025 updated by: University Medical Center Groningen

Comparative Safety Analysis: PET vs. CT Scans During Intensive Care Admission

The goal of this study is to assess how safe it is for critically ill patients in the Intensive Care Unit (ICU) to undergo a PET scan. A PET scan is a type of medical imaging used to help determine why a patient is sick. It is similar to a CT scan but involves a small amount of radioactivity to highlight areas of concern in the body.

For a PET scan, patients need to be transported from the ICU to the scanning room, which can be risky because ICU patients are often very fragile. After a patient gets the PET scan injection, their body gives off a small amount of radiation for a short time. Because of this, doctors and nurses have to keep some distance to protect themselves. This means they keep an eye out for the patient from a bit further away than normal. This makes the procedure slightly riskier, especially for very sick patients.

This study aims to answer the question:

Is getting a PET scan riskier for ICU patients than a regular CT scan?

All patients in this study will continue to receive their usual critical care. Researchers will closely monitor the scanning process to evaluate its safety.

PET scans are already widely used to detect cancer, but new advancements may allow us to use them more often to diagnose infections. Before this can become routine practice, we need to ensure that PET scanning is just as safe as other commonly used imaging techniques. This study will assess all ICU patients undergoing a PET scan-regardless of the reason for the scan-to determine how safe the procedure is in critically ill individuals.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cornelis Paul van Stee, MD
  • Phone Number: 13486 +31655256893
  • Email: fapi-ards@umcg.nl

Study Contact Backup

  • Name: Janesh Pillay, MD, PhD

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713GZ
        • University Medical Center Groningen
        • Contact:
          • Cornelis Paul van Stee, MD
          • Phone Number: 13486 +31655256893
          • Email: fapi-ards@umcg.nl
        • Contact:
          • Janesh Pillay, MD, PhD
        • Contact:
          • Cornelis Paul van Stee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Only patients admitted to the Intensive Care Unit (ICU) will be studied.

Description

Inclusion Criteria:

  • Patients receiving PET/CT during ICU admission (any indication)
  • Patients undergoing CT Thorax/Abdomen (matched cohort)

Exclusion Criteria:

  • CT-scan for any acute indication (acute danger to vital parameters).
  • CT-Cerebrum
  • Registrion in the dutch Objection to medical research registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PET/CT
Patients undergoing a PET/CT for any reason will be evaluated for safety.
CT
All patients undergoing a (planned) CT-Thorax/Abdomen will be included in the analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Measured during the transport phase and 4 hours after return to the Intensive Care Unit.

All adverse events associated with imaging procedures (PET and CT) This will encompass (amongst others) oxygen desaturation, bronchospasm, accidental extubation, hypo-/hypertension, cardiac arrest, malfunctioning medical devices, lack of necessary medication etc.)

Timeframe: Start transport to PET/CT scanner and 4 hours hands-off time.

We will score the noted adverse events in a grading scale adapted from the Clavien-Dindo classification that surgeons use to grade the severity of post-operative complications.
Measured during the transport phase and 4 hours after return to the Intensive Care Unit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Employee dosimetry
Time Frame: Transport and the hands-off time after scan (i.e. 4h in case of [18]FDG PET scanning)

With regards to radiation protection all medical personnel involved in the (PET) procedure will wear electronic personal dosimetry device to ensure they fall into risk categories as outlined by law.

Timeframe: Start at injection of radiopharmaceutical for 4 hours (=hands-off period)
Transport and the hands-off time after scan (i.e. 4h in case of [18]FDG PET scanning)
Dietary Adjustment
Time Frame: 24-48 hours before scan procedure and until 24 hours after cessation of the diet.

The effect of the application of dietary adjustments (Ketogenic diet or fasting) on patient safety. Evaluating the incidence of hypertriglyceridemia, pancreatitis and hypo-/hyperglykemia in both patient groups.

Timeframe: Initiation of preparatory diet for PET-scan. Normally 24 hours - 48 hours before scan until 24 hours after cessation of the diet.
24-48 hours before scan procedure and until 24 hours after cessation of the diet.
Kidney failure (KDIGO)
Time Frame: Day of the scan and up to 3 days after the scan to evaluate the effect on kidney function (i.e. creatinine and urine creatinine will be measured 4 times and evaluated for significant alterations after the application of iodine contrast (if given))
To evaluate the incidence of kidney failure when I.V. contrast is applied. Serum creatinine and 24 hours urine creatinine will be checked to estimate clearance
Day of the scan and up to 3 days after the scan to evaluate the effect on kidney function (i.e. creatinine and urine creatinine will be measured 4 times and evaluated for significant alterations after the application of iodine contrast (if given))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie the results in the publication will be made available upon request by other researchers.

IPD Sharing Time Frame

Once data collection has been completed, data will be made available on request. Ergo circa April 2027.

IPD Sharing Access Criteria

Only data gathered to answer the primary research question posed in this study will be made available and only upon request via the primary researcher.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intensive Care Medicine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe