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

Sponsor
Aalborg University Hospital
Study ID
NCT07185958
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 22, 2025
Start date
Sep 22, 2025
Status verified
Sep 2025
Primary completion
Mar 21, 2028
Completion
Mar 21, 2028

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: DART Brain (whole)
    Patients with 1-5 brain metastases referred for whole brain radiotherapy. Intervention: Extra DECT scan with iodine-based contrast agent + extra MRI scan with Gadolinium-based contrast agent.
  • Arm: DART Brain (SRS)
    Patients with 1-5 brain metastases referred for stereotactic radiotherapy. Intervention: Extra DECT scan with iodine-based contrast agent.
  • Arm: DART Bone (pall)
    Patients with bone metastases without medullary involvement in one or more regions of the vertebral column (C1-C7, Th1-12, L1-L5, Os Sacrum) referred for palliative radiotherapy. Intervention: Extra DECT scan with iodine-based contrast agent + extra MRI scan without contrast agent.
  • Arm: DART Bone (SBRT)
    Patients with bone metastases without medullary involvement in one or more regions of the vertebral column (C1-C7, Th1-12, L1-L5, Os Sacrum) referred for palliative radiotherapy. Intervention: Extra DECT scan with iodine-based contrast agent.
  • Arm: DART H&N
    Patients with head and neck cancer referred for radiotherapy. Patients must have undergone a PET/CT scan during the diagnostic evaluation for cancer. Intervention: Extra DECT scan without contrast agent.
  • Arm: DART Lung
    Patients with lung cancer referred for palliative radiotherapy with a maximum of 10 fractions. Interventions: Extra DECT scan in breath-hold without contrast agent.

Primary Outcome Measure

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) ]

Central Contacts

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