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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07185958
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Aalborg University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hella MB Sand, Medical Physicist, MSc
Principal Investigator Affiliation	Department of Medical Physics, Oncology, Aalborg University Hospital, Aalborg, Denmark
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Denmark
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases, Bone Metastases, Head and Neck Cancer, Lung Cancer

Additional Details

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

Arms & Interventions

Arms

: 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.

: DART Brain (SRS)

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

: DART Bone (SBRT)

: 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.

: 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.

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.

Contact a Trial Team

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International Sites

Aalborg University Hospital, Aalborg 2624886, Denmark

Status

Address

Aalborg University Hospital

Aalborg 2624886, , 9000

Site Contact

Hella MB Sand, Medical Physicist, MSc

[email protected]

+45 97 66 15 84

Herlev 2620431, Denmark

Status

Address

Copenhagen University Hospital Herlev and Gentofte

Herlev 2620431, , 2730

Site Contact

Jens Edmund, Medical Physicist, MSc, PhD

[email protected]

+45 38 68 26 48

Odense University Hospital, Odense 2615876, Denmark

Status

Address

Odense University Hospital

Odense 2615876, , 5000

Site Contact

Tine Schytte, Clinical Oncologist, MD, PhD

[email protected]

+45 40 23 91 93

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