NCT07185958Toboroz
Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 29.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 80 (tervezett)
- Első benyújtás
- 2025. szept. 7.
- Kezdés
- 2025. okt. 14.
- Elsődleges befejezés
- 2028. márc. 21.
- Fő szponzor
- Aalborg University Hospital
- Betegségek
- Fej-nyaki daganatok, Tüdőrák
- NCT-szám
- NCT07185958
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 80
- 2025. okt. 14. és az elsődleges befejezés (2028. márc. 21.) között
- 3 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Previous RT in the same anatomical area now referred for RT
- Previous surgery in the same anatomical area now referred for RT
- If relevant for the protocol scanning regime: Contraindication for MRI (pacemaker, metal, non-MRI, compatible implants etc.)
Más betegség
- If relevant for the protocol scanning regime: Allergic to contrast agent
Egyéb
- Pregnancy
- Participation in conflicting protocols
- 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)
- Incapable of understanding the patient information
Kiket keres a vizsgálat
- 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
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Aalborg University Hospital | Aalborg | Dánia | Toboroz |
| Copenhagen University Hospital Herlev and Gentofte | Herlev | Dánia | Toborzás még nem indult |
| Odense University Hospital | Odense | Dánia | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.