MR-beeldvormingsonderzoek met behulp van de Northern Alberta Linac-MR (Northern LIGHTs - 1)
Northern Alberta Linac-MR Image-Guided Human Clinical Trials - 1
Cancers are often treated with external beam radiotherapy. Current radiotherapy treatments are performed using computed tomography (also known as CT) scans which may not always clearly identify the cancer. In some instances, magnetic resonance imaging (MRI) may be able to better identify cancers. Therefore, efforts are currently underway to use the MRI scans to improve radiotherapy treatments or eventually even use radiotherapy equipment that only uses MRI scans to guide treatments. This new technology that will only use MRI scans to guide treatments is called the Linac-MR (linear accelerator with an MRI). The purpose of this pilot phase of the study is to test whether the Alberta linac-MR P3 system at the Cross Cancer Institute can acquire high quality MR images safely. It will allow the researchers to develop the best collection of MR images possible with this new machine, in order to allow them to visualize tumors for future patients that are treated on this machine.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This prospective, pilot phase, clinical trial is an imaging study to optimize the necessary MR sequences on the Alberta linac-MR P3 system to allow for MR-guided radiotherapy in adult patients with cancer that are treated with high dose external beam radiotherapy. Each participant will undergo a single MR imaging session (30 - 40 minutes) on the Alberta linac-MR P3 system. Towards the end of the study, patients will be approached to participate in an optional sub-study, where they will undergo a total of five MR imaging sessions (performed every two to five days) to allow for an assessment of inter-fraction motion.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Nawaid Usmani, MD
- Telefoonnummer: 780-432-8518
- E-mail: Nawaid.Usmani@ahs.ca
Studie Locaties
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Werving
- Cross Cancer Institute
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Adults ≥ 18 years of age
- Patients deemed fit to undergo high dose external beam radiation therapy by their attending radiation oncologist
Exclusion Criteria:
- Patients with contraindications for MRI
- Patients who are unable to lie flat and still for the duration of the expected scan acquisition
- Patients who are unable to provide informed consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Toestel Haalbaarheid
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: MR Imaging on the Alberta linac-MR P3 system
All participants will undergo a single MR imaging session (30-40 minutes) on the Alberta linac-MR P3 system. |
Single MR imaging session to develop and optimize the necessary MR sequences on the Alberta linac-MR P3 system to allow for MR-guided radiotherapy. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of high-quality MR image data sets acquired for each major tumour site (prostate, liver, lung, CNS, breast, gynecological, pancreas, and head and neck)
Tijdsspanne: Through study completion, approximately 7 years
|
Clinical radiologists, medical physicists, and radiation oncologists will work together to develop MR sequences that can delineate tumour target volumes on the Alberta linac-MR P3 system. Over the course of the trial, the clinical radiologists will work with medical physicists to optimize these sequences to allow for the development of optimal MR images, with the goal to develop of series of protocols that can be utilized to provide clear MR image guidance for each tumour group. |
Through study completion, approximately 7 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Quantify the patient experience on the Linac-MR
Tijdsspanne: After the first and last scan, up to 5 weeks
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Participants will complete a questionnaire at the end of their first scan regarding their experience having imaging done on the Linac-MR. Participants taking part in the optional sub-study will complete the same questionnaire at the end of their last set of imaging. |
After the first and last scan, up to 5 weeks
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Nawaid Usmani, MD, Cross Cancer Institute, Alberta Health Services
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IIT-0013
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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