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Transportation of PatientsCASANCT06912464

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

An observational study of Transportation of Patients and PET / CT, run by University Medical Center Groningen at 1 site in Netherlands.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
208 participants
Where
1 siteNetherlands
Study dates
1 Apr 2025to 1 Apr 2027
How long will I take part?
2 Days
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cornelis Paul Van Stee, MD contact

+31655256893 ext. 13486

fapi-ards@umcg.nl

Janesh Pillay, MD, PhD contact

Netherlands1 site

  • University Medical Center Groningen

    Groningen, Provincie Groningen, 9713GZ

    Cornelis Paul van Stee, MD, +31655256893 ext. 13486, fapi-ards@umcg.nl

    Cornelis Paul van Stee, MD

Other trials in Netherlands

About this study

Official title: 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.

Read more

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.

Keywords
Intrahospital transport (IHT), Intensive Care Medicine, ICU, PET, PET/CT, Safety, CT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06912464
Study groupRoleWhat they receive
PET/CTPatients undergoing a PET/CT for any reason will be evaluated for safety.
CTAll patients undergoing a (planned) CT-Thorax/Abdomen will be included in the analysis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    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: Measured during the transport phase and 4 hours after return to the Intensive Care Unit.

Secondary outcomes (3)

  1. Employee dosimetry

    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)

    Measured: Transport and the hands-off time after scan (i.e. 4h in case of [18]FDG PET scanning)

  2. Dietary Adjustment

    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.

    Measured: 24-48 hours before scan procedure and until 24 hours after cessation of the diet.

  3. Kidney failure (KDIGO)

    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

    Measured: 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))

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
208 participants (estimated)
Target duration
2 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06912464
Sponsor's protocol ID
20649
Acronym
CASA
Status last verified
Feb 2025
First submitted
20 Mar 2025
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie the results in the publication will be made available upon request by other researchers.

Publications

  • Baldetti L, Busnardo E, Pazzanese V, Ricchetti G, Barone G, Sacchi S, Calvo F, Gramegna M, Pieri M, Ingallina G, Camici PG, Ajello S, Scandroglio AM. Myocardial viability assessment during Impella support with 18-fluorodesoxyglucose PET imaging. ESC Heart Fail. 2025 Feb;12(1):683-687. doi: 10.1002/ehf2.15053. Epub 2024 Sep 6.

    PubMed 39239887

  • Slart RHJA, Tsoumpas C, Glaudemans AWJM, Noordzij W, Willemsen ATM, Borra RJH, Dierckx RAJO, Lammertsma AA. Long axial field of view PET scanners: a road map to implementation and new possibilities. Eur J Nucl Med Mol Imaging. 2021 Dec;48(13):4236-4245. doi: 10.1007/s00259-021-05461-6. Epub 2021 Jun 16.

    PubMed 34136956

  • Schwebel C, Clec'h C, Magne S, Minet C, Garrouste-Orgeas M, Bonadona A, Dumenil AS, Jamali S, Kallel H, Goldgran-Toledano D, Marcotte G, Azoulay E, Darmon M, Ruckly S, Souweine B, Timsit JF; OUTCOMEREA Study Group. Safety of intrahospital transport in ventilated critically ill patients: a multicenter cohort study*. Crit Care Med. 2013 Aug;41(8):1919-28. doi: 10.1097/CCM.0b013e31828a3bbd.

    PubMed 23863225

  • Bercault N, Wolf M, Runge I, Fleury JC, Boulain T. Intrahospital transport of critically ill ventilated patients: a risk factor for ventilator-associated pneumonia--a matched cohort study. Crit Care Med. 2005 Nov;33(11):2471-8. doi: 10.1097/01.ccm.0000185644.54646.65.

    PubMed 16276168

  • Parmentier-Decrucq E, Poissy J, Favory R, Nseir S, Onimus T, Guerry MJ, Durocher A, Mathieu D. Adverse events during intrahospital transport of critically ill patients: incidence and risk factors. Ann Intensive Care. 2013 Apr 12;3(1):10. doi: 10.1186/2110-5820-3-10.

    PubMed 23587445

  • Waydhas C. Intrahospital transport of critically ill patients. Crit Care. 1999;3(5):R83-9. doi: 10.1186/cc362. Epub 1999 Sep 24.

    PubMed 11094486

  • Murata M, Nakagawa N, Kawasaki T, Yasuo S, Yoshida T, Ando K, Okamori S, Okada Y. Adverse events during intrahospital transport of critically ill patients: A systematic review and meta-analysis. Am J Emerg Med. 2022 Feb;52:13-19. doi: 10.1016/j.ajem.2021.11.021. Epub 2021 Nov 20.

    PubMed 34861515

  • Venkategowda PM, Rao SM, Mutkule DP, Taggu AN. Unexpected events occurring during the intra-hospital transport of critically ill ICU patients. Indian J Crit Care Med. 2014 Jun;18(6):354-7. doi: 10.4103/0972-5229.133880.

    PubMed 24987233

  • Brunsveld-Reinders AH, Arbous MS, Kuiper SG, de Jonge E. A comprehensive method to develop a checklist to increase safety of intra-hospital transport of critically ill patients. Crit Care. 2015 May 7;19(1):214. doi: 10.1186/s13054-015-0938-1.

    PubMed 25947327

  • van Leer B, van Rijsewijk ND, Nijsten MWN, Slart RHJA, Pillay J, Glaudemans AWJM. Practice of 18F-FDG-PET/CT in ICU Patients: A Systematic Review. Semin Nucl Med. 2023 Nov;53(6):809-819. doi: 10.1053/j.semnuclmed.2023.05.003. Epub 2023 May 29.

    PubMed 37258380

  • van Snick JH, van Leer B, Nijsten MWN, Pillay J, Slart RHJA, Glaudemans AWJM, van Rijsewijk ND. Long axial field of view PET/CT in critically ill patients: lessons from a case report. Front Med (Lausanne). 2024 Jan 4;10:1347791. doi: 10.3389/fmed.2023.1347791. eCollection 2023.

    PubMed 38239612

Questions about this trial

What is this clinical trial studying?

An observational study of Transportation of Patients and PET / CT, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cornelis Paul Van Stee, MD (+31655256893 ext. 13486, fapi-ards@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Measured during the transport phase and 4 hours after return to the Intensive Care Unit.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06912464, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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