Brain MetastasesDARTNCT07185958
Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy
An observational study of Brain Metastases and Bone Metastases, run by Aalborg University Hospital at 3 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Bone Metastases, Head and Neck Cancer
- What is being tested?
- Dual-energy CT (DECT), Iodine-based contrast agent and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 3 sitesDenmark
- Study dates
- 14 Oct 2025to 21 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients referred for radiotherapy at Aalborg University Hospital, Denmark. For the 'DART Bone (SBRT)' cohort, patients are also referred for radiotherapy at Odense University Hospital and Copenhagen University Hospital, Herlev and Gentofte, Denmark
Who may be able to join
- Age ≥18 years
- ECOG performance status (PS) 0-2
- Assessed to be able to complete the protocol scanning regime
- Referred for RT
- Signed informed consent
- For patients with brain metastasis (cohort A): 1-5 brain metastases referred for ei-ther whole brain or stereotactic RT
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- For patients with bone metastasis (cohort B): Metastases in one or more regions of the vertebral column (C1-C7, Th1-12, L1-L5, Os Sacrum), without medullary involve-ment, referred for either palliative or stereotactic RT
- For head and neck cancer patients (cohort C): A PET/CT scan must have been per-formed during the diagnostic evaluation for cancer
- For lung cancer patients (cohort D): Only patients referred for palliative RT with a maximum of 10 fractions
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Hella MB Sand, Medical Physicist, MSc, +45 97 66 15 84, hmbs@rn.dk
Laurids Ø Poulsen, Clinical Oncologist, MD, PhD, +45 97 66 67 95, laop@rn.dk
- Not yet recruiting
Copenhagen University Hospital Herlev and Gentofte
Herlev, 2730
Jens Edmund, Medical Physicist, MSc, PhD, +45 38 68 26 48, jens.edmund@regionh.dk
Gitte Persson, Clinical Oncologist, MD, PhD
- Recruiting
Odense University Hospital
Odense, 5000
Tine Schytte, Clinical Oncologist, MD, PhD, +45 40 23 91 93, tine.schytte@rsyd.dk
Tine Bjørn, Medical Physicst, MSc, PhD
About this study
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.
Read the detailed description
A detailed description of the study is provided in the uploaded document 'Study Protocol with Statistical Analysis Plan'.
- Conditions
- Brain Metastases, Bone Metastases, Head and Neck Cancer, Lung Cancer
- Being tested
- Dual-energy CT (DECT), Iodine-based contrast agent, Magnetic Resonance Imaging (MRI), Gadolinium-based contrast agent
- Keywords
- tumor delineation, organs at risk delineation, dual-energy CT, DECT, radiotherapy
- Medical subject headings
- Brain Neoplasms, Head and Neck Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-energy CT (DECT)Diagnostic test
Additional DECT scan performed for tumor and OAR delineation.
Iodine-based contrast agentDrug
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 agentDrug
Administered intravenously with MRI for enhanced imaging.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Dual-energy CT (DECT); Drug: Iodine-based contrast agent; Diagnostic Test: Magnetic Resonance Imaging (MRI); Drug: Gadolinium-based contrast agent | |
| DART Brain (SRS) | Patients with 1-5 brain metastases referred for stereotactic radiotherapy. Intervention: Extra DECT scan with iodine-based contrast agent. Receives: Diagnostic Test: Dual-energy CT (DECT); Drug: Iodine-based contrast agent | |
| 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. Receives: Diagnostic Test: Dual-energy CT (DECT); Drug: Iodine-based contrast agent; Diagnostic Test: Magnetic Resonance Imaging (MRI) | |
| 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. Receives: Diagnostic Test: Dual-energy CT (DECT); Drug: Iodine-based contrast agent | |
| 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. Receives: Diagnostic Test: Dual-energy CT (DECT) | |
| 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. Receives: Diagnostic Test: Dual-energy CT (DECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-observer variability (geometric differences in volume and surface) of manual tumor and OAR delineations on DECT compared with SECT/MRI.
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.
Measured: Baseline (time of imaging before radiotherapy planning)
Secondary outcomes (1)
Qualitative image-quality assessment of tumors and OARs using a Likert scale (or comparable method) for DECT compared with SECT/MRI.
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 5-point Likert scale (ranging from 1 to 5, where a score of 1 represents the highest image quality and 5 represents the lowest/worst quality). Evaluations will be made and reported between DECT and SECT/MRI scans (and, for patients enrolled in 'DART H\&N', also PET/CT scans).
Measured: Baseline (time of imaging before radiotherapy planning)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start14 Oct 2025
- Primary completion21 Mar 2028 (estimated)
- Study completion21 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Odense University Hospital
- Responsible party
- Principal investigator, Hella Maria Brøgger Sand, Aalborg University Hospital
- Investigators
- Hella MB Sand, Medical Physicist, MSc, Principal investigator, Department of Medical Physics, Oncology, Aalborg University Hospital, Aalborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185958
- Sponsor's protocol ID
- N-20250004
- Acronym
- DART
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy
- ClinicalTrials.gov ID
- NCT07185958
- Acronym / sponsor ID
- DART / N-20250004
- Conditions
- Brain Metastases, Bone Metastases, Head and Neck Cancer, Lung Cancer
- Keywords
- tumor delineation, organs at risk delineation, dual-energy CT, DECT, radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Odense University Hospital
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 21 Mar 2028 (estimated)
- Study completion
- 21 Mar 2028 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
A detailed description of the study is provided in the uploaded document 'Study Protocol with Statistical Analysis Plan'.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| DART Brain (whole) | – | Diagnostic Test: Dual-energy CT (DECT), Drug: Iodine-based contrast agent, Diagnostic Test: Magnetic Resonance Imaging (MRI), Drug: Gadolinium-based contrast agentPatients 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. |
| DART Brain (SRS) | – | Diagnostic Test: Dual-energy CT (DECT), Drug: Iodine-based contrast agentPatients with 1-5 brain metastases referred for stereotactic radiotherapy. Intervention: Extra DECT scan with iodine-based contrast agent. |
| DART Bone (pall) | – | Diagnostic Test: Dual-energy CT (DECT), Drug: Iodine-based contrast agent, Diagnostic Test: Magnetic Resonance Imaging (MRI)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. |
| DART Bone (SBRT) | – | Diagnostic Test: Dual-energy CT (DECT), Drug: Iodine-based contrast agentPatients 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. |
| DART H&N | – | Diagnostic Test: Dual-energy CT (DECT)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. |
| DART Lung | – | Diagnostic Test: Dual-energy CT (DECT)Patients with lung cancer referred for palliative radiotherapy with a maximum of 10 fractions. Interventions: Extra DECT scan in breath-hold without contrast agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients referred for radiotherapy at Aalborg University Hospital, Denmark. For the 'DART Bone (SBRT)' cohort, patients are also referred for radiotherapy at Odense University Hospital and Copenhagen University Hospital, Herlev and Gentofte, Denmark
Key inclusion criteria (9 listed)
- Age ≥18 years
- ECOG performance status (PS) 0-2
- Assessed to be able to complete the protocol scanning regime
- Referred for RT
- Signed informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-energy CT (DECT)Additional DECT scan performed for tumor and OAR delineation. | Diagnostic test | DART Bone (SBRT), DART Bone (pall), DART Brain (SRS), DART Brain (whole), DART H&N, DART Lung |
| Iodine-based contrast agentAdministered intravenously with DECT for enhanced imaging. | Drug | DART Bone (SBRT), DART Bone (pall), DART Brain (SRS), DART Brain (whole) |
| Magnetic Resonance Imaging (MRI)Additional MRI scan performed for tumor and OAR delineation. | Diagnostic test | DART Bone (pall), DART Brain (whole) |
| Gadolinium-based contrast agentAdministered intravenously with MRI for enhanced imaging. | Drug | DART Brain (whole) |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hella MB Sand, Medical Physicist, MSc principal investigator
Department of Medical Physics, Oncology, Aalborg University Hospital, Aalborg, Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases and Bone Metastases, run by Aalborg University Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hella MB Sand, Medical Physicist, MSc (+45 97 66 15 84, hmbs@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.