Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy

NCT07185958 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-09-22

No results posted yet for this study

Summary

The primary aim of this clinical study, 'Dual Energy CT - a tool for delineation of tumor and organs at risk in radiotherapy' (DART) is to evaluate whether dual-energy CT (DECT) is at least as effective as magnetic resonance imaging (MRI) in delineating both tumors and organs at risk (OARs) in patients referred for radiotherapy (RT). This primary aim will be explored in patient groups where the performance of DECT for RT has been described in the literature (but mostly based on signal-to-noise ratio and/or contrast-to-noise ratio), such as brain metastases (sub-cohort 'DART Brain') and head and neck cancer (sub-cohort 'DART H\&N'). Additionally, DART will explore diagnoses not yet studied in the literature, such as bone metastases (sub-cohort 'DART Bone'). If DECT could be demonstrated to achieve delineations for RT in both tumors and OARs that are equally accurate as those based on MRI, it could offer significant advantages by being faster and more cost-effective, making DECT a valuable alternative to MRI in clinical practice. As a secondary aim, the study will evaluate whether DART offers benefits when added to standard RT imaging for tumor and OAR delineation: (1) For lung cancer patients (sub-cohort 'DART Lung'), where MRI scans are typically not valuable due to tumor motion caused by breathing, 'DART Lung' will assess whether DECT performed in breath-hold provides added value compared to the single-energy CT (SECT) scan conducted during free breathing, as used in current clinical practice. (2) For head and neck cancer patients, 'DART H\&N' will evaluate whether DECT offers added value compared to the positron emission tomography (PET)/CT scan currently used in clinical practice.

Conditions

Interventions

DIAGNOSTIC_TEST

Dual-energy CT (DECT)

Additional DECT scan performed for tumor and OAR delineation.

DRUG

Iodine-based contrast agent

Administered intravenously with DECT for enhanced imaging.

DIAGNOSTIC_TEST

Magnetic Resonance Imaging (MRI)

Additional MRI scan performed for tumor and OAR delineation.

DRUG

Gadolinium-based contrast agent

Administered intravenously with MRI for enhanced imaging.

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    collaborator OTHER
  • Odense University Hospital

    collaborator OTHER
  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Hella MB Sand, Medical Physicist, MSc · Department of Medical Physics, Oncology, Aalborg University Hospital, Aalborg, Denmark

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-22
Primary Completion
2028-03-21
Completion
2028-03-21

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07185958 on ClinicalTrials.gov