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NCT Number: NCT07185958

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

A detailed description of the study is provided in the uploaded document 'Study Protocol with Statistical Analysis Plan'.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ECOG performance status (PS) 0-2
  • Assessed to be able to complete the protocol scanning regime
  • Referred for RT
  • For head and neck cancer patients, a PET/CT scan must have been performed during the diagnostic evaluation for cancer
  • Signed informed consent

Exclusion criteria

  • Pregnancy
  • Previous RT in the same anatomical area now referred for RT
  • Previous surgery in the same anatomical area now referred for RT
  • Participation in conflicting protocols
  • If relevant for the protocol scanning regime: Allergic to contrast agent
  • If relevant for the protocol scanning regime: Contraindication to iodine-based contrast agent for CT (as determined by the physician)
  • If relevant for the protocol scanning regime: Contraindication to Gadolinium-based contrast agent for MRI (as determined by the physician)
  • If relevant for the protocol scanning regime: Contraindication for MRI (pacemaker, metal, non-MRI, compatible implants etc.)
  • Incapable of understanding the patient information

Treatment and study plan

Dual-energy CT (DECT)

Diagnostic Test

Additional DECT scan performed for tumor and OAR delineation.

Iodine-based contrast agent

Drug

Administered intravenously with DECT for enhanced imaging.

Magnetic Resonance Imaging (MRI)

Diagnostic Test

Additional MRI scan performed for tumor and OAR delineation.

Gadolinium-based contrast agent

Drug

Administered intravenously with MRI for enhanced imaging.

Primary outcomes

  1. Inter-observer variability (geometric differences in volume and surface) of manual tumor and OAR delineations on DECT compared with SECT/MRI.

    Time frame: Baseline (time of imaging before radiotherapy planning)

    For patients enrolled in cohorts 'DART Brain', 'DART Bone' and 'DART H&N', the accuracy of manual delineations of tumors and OARs on DECT scans will be compared to those manually performed on a combination of SECT and MRI scans for each patient. For patients enrolled in 'DART H&N' the comparison will also be done to the PET/CT scan.

    A reduction in inter-observer variability in delineations will serve as an indicator of improved contour accuracy for both tumors and OARs. Inter-observer variability for tumor and OAR delineations on DECT and SECT/MRI scans, respectively, will be measured as geometric differences between individual manual delineations and consensus structures for each tumor and OAR. Consensus structures will be generated on both DECT and SECT/MRI scans using the STAPLE function with a 50% agreement threshold. Variations relative to the consensus structures will be reported using various metrics, including volume and surface differences.

Secondary outcomes

  1. Qualitative image-quality assessment of tumors and OARs using a Likert scale (or comparable method) for DECT compared with SECT/MRI.

    Time frame: Baseline (time of imaging before radiotherapy planning)

    The secondary outcome will be measured in all patient cohorts ('DART Brain', 'DART Bone', 'DART H&N', and 'DART Lung'). Image-quality for tumors and OARs will be evaluated qualitatively by experienced oncologists using a Likert scale or comparable method, and evaluations will be made and reported between DECT and SECT/MRI scans (and, for patients enrolled in 'DART H&N', also PET/CT scans).

Study contacts

Contact information is provided by the study sponsor or research team.

Hella MB Sand, Medical Physicist, MSc

CONTACT

[email protected]

+45 97 66 15 84

Laurids Ø Poulsen, Clinical Oncologist, MD, PhD

CONTACT

[email protected]

+45 97 66 67 95

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Copenhagen University Hospital at Herlev
  • Odense University Hospital

Registry information

Acronym: DART

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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