Dual Energy CT to Delineate Tumors and Organs at Risk in Radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares dual-energy CT with MRI for outlining tumors and organs at risk in patients referred for radiotherapy. It includes brain metastases, head and neck cancer, bone metastases, and lung cancer cohorts to see if DECT can match MRI in accuracy and potentially be faster and more cost-effective. Participants are adults with good performance status who are planned for RT, and imaging will involve DECT with iodine contrast, MRI with gadolinium, and standard clinical data. The study aims to determine noninferiority or equivalence in delineation quality to support DECT as an alternative imaging option in RT planning.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years
2. ECOG performance status (PS) 0-2
3. Assessed to be able to complete the protocol scanning regime
4. Referred for RT
5. Signed informed consent
6. For patients with brain metastasis (cohort A): 1-5 brain metastases referred for ei-ther whole brain or stereotactic RT
7. 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
8. For head and neck cancer patients (cohort C): A PET/CT scan must have been per-formed during the diagnostic evaluation for cancer
9. For lung cancer patients (cohort D): Only patients referred for palliative RT with a maximum of 10 fractions

Exclusion Criteria:

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

Where it's running

• Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting
• Copenhagen University Hospital Herlev and Gentofte
  Herlev, Denmark Not yet recruiting

Study contacts

• Principal investigator: Hella MB Sand, Medical Physicist, MSc — Department of Medical Physics, Oncology, Aalborg University Hospital, Aalborg, Denmark
• Study coordinator: Hella MB Sand, Medical Physicist, MSc
• Email: hmbs@rn.dk
• Phone: +45 97 66 15 84

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.