- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Greater Manchester
-
Manchester, Greater Manchester, Regno Unito, M20 4BX
- Reclutamento
- The Christie NHS Foundation Trust
-
Investigatore principale:
- Corinne Faivre-Finn
-
Sub-investigatore:
- Ananya Choudhury
-
Contatto:
- Julie Stratford
- Numero di telefono: 0044 (0)161 446 3506
- Email: julie.stratford@christie.nhs.uk
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Cone Beam Computed Tomography
Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy.
|
Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Equivalence of image quality
Lasso di tempo: 12 months
|
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.
|
12 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quantify inter-observer variation
Lasso di tempo: 12 months
|
To quantify inter-observer variation in interpretation of anatomy, as assessed by questionaires.
|
12 months
|
|
Quantify inter-observer variation
Lasso di tempo: 12 months
|
To quantify inter-observer variation in delineation of specific structures on CBCT scans.
|
12 months
|
|
Quantify impact on treatment times.
Lasso di tempo: 12 months
|
To quantify the impact of simultaneous CBCT scans on treatment times.
|
12 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ananya Choudhury, The Christie NHS Foundation Trust
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10_RADIO_94
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .