- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02503917
Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound (GENIUS)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Radiotherapy is an established and effective method for treating cancer, but it can have negative side effects if healthy tissues are also exposed to radiation. In the case of cervical cancer, the bladder, small bowel, and bone marrow are often irradiated, which can result in both short-term and long-term side effects. There are sophisticated radiation delivery techniques (known as IMRT and VMAT) which are capable of administering the radiation dose in a precise and controlled manner so that the intended target is irradiated and the healthy tissue is spared. However, the only way for these sophisticated radiation delivery methods to work in cervical cancer is to localise the uterus prior to radiotherapy treatment so that the lineup between the radiation beam and the target is ensured. The uterus is a relatively mobile organ, and can have very different positions within the body depending on the patient position, bladder volume, tumour site, etc. Currently, we are unable to take advantage of the sophisticated radiation delivery techniques as we have no reliable way of seeing where the uterus is. Ultrasound is a promising way to overcome this problem.
Ultrasound is non-ionising, has good soft-tissue contrast, and can easily be incorporated into the radiation treatment room. We wish to establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images. This will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Surrey
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Sutton, Surrey, Royaume-Uni, SM2 5PT
- Recrutement
- Royal Marsden Hospital NHS Foundation Trust
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Contact:
- Julie Curtis
- Numéro de téléphone: 02086713873
- E-mail: julie.curtis@rmh.nhs.uk
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Sous-enquêteur:
- Sarah Mason
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- healthy volunteer cohort: Healthy female adult volunteers
- patient volunteer cohort: Patients receiving radiotherapy for cervical cancer who will receive a planning CT scan and daily CBCT scanning as part of their treatment.
Exclusion Criteria:
- both cohorts: Women who have received hysterectomies and women who are pregnant at the time of the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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Healthy volunteers
Healthy female adult volunteers
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Cervical cancer patients
Patients receiving radiotherapy for cervical cancer at the Royal Marsden who will receive a planning CT scan and daily CBCT scanning as part of their treatment.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour
Délai: DSC calculated at 24 time points for each healthy volunteer (3 days)
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The DSC between the ground truth contour and the algorithm derived contour will indicate the accuracy of the segmentation algorithm.
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DSC calculated at 24 time points for each healthy volunteer (3 days)
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Coefficient of variation between of expert-drawn contours on ultrasound and expert-drawn contours on CBCT
Délai: COV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapy
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A small COV will indicate greater clinician/expert confidence in segmenting the uterus
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COV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapy
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Bland-Altman plot (healthy volunteer cohort)
Délai: 1 day
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Used to describe the level of agreement between MR and ultrasound images of the uterus.
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1 day
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Uterine center of mass displacement on ultrasound (healthy volunteer cohort)
Délai: 3 days
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Assess both inter- and intra- fractional motion of the uterus.
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3 days
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Expert confidence scores for each imaging modality (ultrasound and MR) (healthy volunteer cohort)
Délai: from data collected over 3 days
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Determine if uterine segmentation on ultrasound receives acceptable confidence score compared with MR
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from data collected over 3 days
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Bland-Altman plot (patient volunteer cohort)
Délai: 6 weeks
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describe level of agreement among the COV, circularity index, volume, and centre of mass position betweeen ultrasound, CT, and CBCT.
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6 weeks
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Expert confidence scores for each imaging modality (ultrasound, CT, and CBCT) (patient volunteer cohort)
Délai: from data collected over 6 weeks
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Determine if uterine segmentation on ultrasound receives greater confidence score compared with CT and CBCT.
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from data collected over 6 weeks
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Susan Lalondrelle, Royal Marsden Hospital 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
- CCR4342
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