- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02123888
Simultaneous CBCT Acquisition During Arc Radiotherapy (SCART)
Simultaneous Cone Beam Computed Tomography (CBCT) Acquisition During Arc Radiotherapy
The cone beam image is a part of the radiotherapy treatment machine and uses lower energy xrays as the head of the radiotherapy machine moves around the patient in a circle. This takes pictures that give 3-dimensional information, somewhat like a CT scan. These images are better at showing the position of the tumour and surrounding soft tissues than the standard xrays that were previously used. Cone Beam Imaging Technology is not new and has been used regularly at The Christie for many years. The standard cone beam scan is taken before the actual radiotherapy treatment or after the treatment has been delivered.
Volumetric Modulated Arc Therapy (VMAT or Arc Radiotherapy) is a novel method of delivering radiotherapy that involves the continuous movement of the radiotherapy treatment machine head around the patient and MLC during radiation. Arc radiotherapy has been clinically implemented at The Christie for prostate radiotherapy treatments and work is in progress for implementation in lung radiotherapy. The continuous gantry rotation inherent to VMAT delivery makes this simultaneous imaging possible, although there are concerns associated with the impact that this may have on patient dose and image quality.
The aim of this research is to assess whether the image quality of cone beam scans taken during treatment are as good as standard cone beam scans taken before or after treatment used to determine the accuracy of patient position and the tumour coverage by radiotherapy.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Greater Manchester
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Manchester, Greater Manchester, Royaume-Uni, M20 4BX
- Recrutement
- The Christie NHS Foundation Trust
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Chercheur principal:
- Corinne Faivre-Finn
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Sous-enquêteur:
- Ananya Choudhury
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Contact:
- Julie Stratford
- Numéro de téléphone: 0044 (0)161 446 3506
- E-mail: julie.stratford@christie.nhs.uk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria for prostate cancer patients:
- Patients to be treated with radical RT for prostate cancer
- Patients to be treated with VMAT
- ECOG performance status 0-2
- Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent
Inclusion Criteria for lung cancer patients:
- A histological or cytological diagnosis of non-small cell lung cancer or small cell lung cancer
- Patients to be treated with radical RT or SBRT
- Patients to be treated with VMAT
- ECOG performance status 0-2
- Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent
- Female patients must meet one of the following criteria - postmenopausal for a minimum of one year, surgically sterile, not pregnant, confirmed by β-HCG blood test and willing to use adequate contraception during study participation, not breastfeeding
Exclusion Criteria for prostate cancer patients:
- Clinical judgement by the investigator that the patient should not participate in the study
- Patients in clinical trials of new investigational medicinal products or treatment regimens unless there is written, prior agreement that the patient can also consent to this study, and that clinical data can also be used for this study
- Prior radiotherapy or surgery in the pelvis that can make identification of normal anatomy difficult
Exclusion criteria for lung cancer patients:
- Clinical judgement by the investigator that the patient should not participate in the study
- Patients in clinical trials of new investigational medicinal products or treatment regimens unless there is written, prior agreement that the patient can also consent to this study, and that clinical data can also be used for this study
- Prior radiotherapy or surgery in the region of interest that can make identification of normal anatomy difficult
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Cone Beam Computed Tomography
Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy.
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Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Equivalence of image quality
Délai: 12 months
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To show equivalence of image quality from simultaneous CBCT acquisition during delivery of arc radiotherapy with that obtained from conventional CBCT acquisition in lung and prostate patients, as assessed by user-questionnaires.
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12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Quantify inter-observer variation
Délai: 12 months
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To quantify inter-observer variation in interpretation of anatomy, as assessed by questionaires.
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12 months
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Quantify inter-observer variation
Délai: 12 months
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To quantify inter-observer variation in delineation of specific structures on CBCT scans.
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12 months
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Quantify impact on treatment times.
Délai: 12 months
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To quantify the impact of simultaneous CBCT scans on treatment times.
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12 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ananya Choudhury, The Christie NHS Foundation Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 10_RADIO_94
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Cone Beam Computed Tomography
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Istituto Ortopedico RizzoliActif, ne recrute pasLuxation fémoropatellaireItalie
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University Health Network, TorontoRecrutement
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University Health Network, TorontoPrincess Margaret Hospital, CanadaComplétéTumeurs prostatiquesCanada
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Implantology InstituteInconnueLa résorption osseuse | Perte osseuse alvéolaire | Perte de dents due à l'extractionLe Portugal
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Hospices Civils de LyonRecrutementCancer du sein métastatique | CBNPC métastatique | Métastases osseusesFrance
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Columbus Regional HealthComplétéMasse pulmonaire | Nodule pulmonaire | Lésion du poumonÉtats-Unis
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University Health Network, TorontoComplété