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

NCT ID: NCT07185958

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-22

Study Completion Date

2028-03-21

Brief Summary

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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.

Detailed Description

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

Conditions

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Brain Metastases Bone Metastases Head and Neck Cancer Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Dual-energy CT (DECT)

Intervention Type DIAGNOSTIC_TEST

Additional DECT scan performed for tumor and OAR delineation.

Iodine-based contrast agent

Intervention Type DRUG

Administered intravenously with DECT for enhanced imaging.

Magnetic Resonance Imaging (MRI)

Intervention Type DIAGNOSTIC_TEST

Additional MRI scan performed for tumor and OAR delineation.

Gadolinium-based contrast agent

Intervention Type DRUG

Administered intravenously with MRI for enhanced imaging.

DART Brain (SRS)

Patients with 1-5 brain metastases referred for stereotactic radiotherapy. Intervention: Extra DECT scan with iodine-based contrast agent.

Dual-energy CT (DECT)

Intervention Type DIAGNOSTIC_TEST

Additional DECT scan performed for tumor and OAR delineation.

Iodine-based contrast agent

Intervention Type DRUG

Administered intravenously with DECT for enhanced imaging.

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.

Dual-energy CT (DECT)

Intervention Type DIAGNOSTIC_TEST

Additional DECT scan performed for tumor and OAR delineation.

Iodine-based contrast agent

Intervention Type DRUG

Administered intravenously with DECT for enhanced imaging.

Magnetic Resonance Imaging (MRI)

Intervention Type DIAGNOSTIC_TEST

Additional MRI scan performed for tumor and OAR delineation.

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.

Dual-energy CT (DECT)

Intervention Type DIAGNOSTIC_TEST

Additional DECT scan performed for tumor and OAR delineation.

Iodine-based contrast agent

Intervention Type DRUG

Administered intravenously with DECT for enhanced imaging.

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.

Dual-energy CT (DECT)

Intervention Type DIAGNOSTIC_TEST

Additional DECT scan performed for tumor and OAR delineation.

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.

Dual-energy CT (DECT)

Intervention Type DIAGNOSTIC_TEST

Additional DECT scan performed for tumor and OAR delineation.

Interventions

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Dual-energy CT (DECT)

Additional DECT scan performed for tumor and OAR delineation.

Intervention Type DIAGNOSTIC_TEST

Iodine-based contrast agent

Administered intravenously with DECT for enhanced imaging.

Intervention Type DRUG

Magnetic Resonance Imaging (MRI)

Additional MRI scan performed for tumor and OAR delineation.

Intervention Type DIAGNOSTIC_TEST

Gadolinium-based contrast agent

Administered intravenously with MRI for enhanced imaging.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hella Maria Brøgger Sand

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hella MB Sand, Medical Physicist, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Physics, Oncology, Aalborg University Hospital, Aalborg, Denmark

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status

Copenhagen University Hospital Herlev and Gentofte

Herlev, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Hella MB Sand, Medical Physicist, MSc

Role: CONTACT

+45 97 66 15 84

Laurids Ø Poulsen, Clinical Oncologist, MD, PhD

Role: CONTACT

+45 97 66 67 95

Facility Contacts

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Hella MB Sand, Medical Physicist, MSc

Role: primary

+45 97 66 15 84

Laurids Ø Poulsen, Clinical Oncologist, MD, PhD

Role: backup

+45 97 66 67 95

Jens Edmund, Medical Physicist, MSc, PhD

Role: primary

+45 38 68 26 48

Tine Schytte, Clinical Oncologist, MD, PhD

Role: primary

+45 40 23 91 93

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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N-20250004

Identifier Type: -

Identifier Source: org_study_id

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