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

Not yet recruiting

• Conditions: Transportation of Patients; PET / CT; Intensive Care Medicine

• Registration Number: NCT06912464
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study Start: 2025-04-01
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Primary Completion: 2027-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 208

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events	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.

Secondary Outcome Measures

Name	Time	Method
Employee dosimetry	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)
Dietary Adjustment	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.
Kidney failure (KDIGO)	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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands