Diagnostic Performance of Low-Dose CT for Acute Abdominal Conditions

NCT05651360 | Completed

• 3 other identifiers: PVO ref. 22/1184022/11840468490
• Study Type: observational
• Target: 246
• Locations: 2 countries
• Sites: 2

Brief Summary

The goal of this non-inferiority observational study is to assess the diagnostic performance of low-dose CT with deep learning image reconstruction (DLIR) in adult participants with acute abdominal conditions. The main research question is: • Can low-dose CT with DLIR achieve the same diagnostic performance as standard CT for the diagnosis of acute abdominal conditions. Participants will be examined with an additional low-dose CT directly after the standard CT. Participant will be their own controls.

Conditions

Abdominal Pain; Acute Pain; Acute Cholecystitis; Acute Appendicitis; Acute Pancreatitis

Keywords

Computed Tomography; Deep learning image reconstruction; Low-dose; Diagnostic performance; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of low-dose CT

  Diagnostic performance of low-dose CT compared to standard CT according to ICD 10 diagnosis. Diagnostic performance measured in terms of: Sensitivity given in % according to TP/(TP+FN); specificity given in % according to TN/(TN+FP); positive predictive value given in % according to TP/(TP+FP); negative predictive value given in % according to TN/(TN+FN); accuracy given in % according to (TP+TN)/(TP+TN+FP+FN). Number true positive (TP); number true negative (TN); number false positive (FP); number false negative (FN).

  4 to 6 months

Secondary Outcomes (5)

• Perceived image quality

  4 to 6 months

• Image quality - noise

  4 to 6 months

• Image quality - contrast-to-noise ratio

  4 to 6 months

• Radiation dose

  4 to 6 months

• Diagnoses

  4 to 6 months

Study Arms (1)

Abdominal Pain

Participants under evaluation for an acute abdominal condition who are referred to CT of the abdomen and pelvis.

Diagnostic Test: low-dose CT

Interventions

low-dose CT DIAGNOSTIC_TEST

Low-dose CT scan will be performed, not exceeding 30% radiation dose of the standard CT. Low-dose CT images will be reconstructed with TrueFidelity high. The low-dose CT will be performed directly after the standard CT to avoid bias from differences in the timing of the contrast phase.

Abdominal Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic; university hospital

You may qualify if:

• Patients under evaluation for an acute abdominal condition who are referred to CT of the abdomen and pelvis.
• Age \>18 years
• The patients must be able to give their oral and written consent to study participation.

You may not qualify if:

• Contraindications regarding contrast enhanced CT examinations like known iodinated contrast media adverse reactions or claustrophobia.
• Pregnancy.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Odense University Hospital: collaborator

Study Sites (2)

Odense University Hospital

Odense, Denmark

Location

Oslo University Hospital

Oslo, Norway

Location

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MeSH Terms

Conditions

Abdominal Pain; Acute Pain; Cholecystitis, Acute; Appendicitis; Pancreatitis; Disease

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases; Pancreatic Diseases; Pathologic Processes

Study Officials

• Anselm Schulz, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 15, 2022
• Study Start: December 7, 2022
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); DK (1)