- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02503917
Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound (GENIUS)
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Surrey
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Sutton, Surrey, Spojené království, SM2 5PT
- Nábor
- Royal Marsden Hospital NHS Foundation Trust
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Kontakt:
- Julie Curtis
- Telefonní číslo: 02086713873
- E-mail: julie.curtis@rmh.nhs.uk
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Dílčí vyšetřovatel:
- Sarah Mason
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Bland-Altman plot (healthy volunteer cohort)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Susan Lalondrelle, Royal Marsden Hospital NHS Foundation Trust
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CCR4342
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