Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05731791
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2023-02-07
Brief Title:
Trial to Compare MRI-guided Precision Prone Irradiation PPI Versus CT-guided Breast Irradiation
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
A Prospective Randomized Trial to Compare MRI-guided Precision Prone Irradiation PPI Versus CT-guided Breast Irradiation
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPI
Brief Summary:
The Investigators are investigating the potential role of MRI-guided Radiation Therapy for patients receiving breast radiotherapy in the prone position with a MRI-Linac radiotherapy system the Precision Prone Irradiation PPI technique
Hypothesis The investigators would like to hypothesize that breast radiation therapy using MRI-guided system including the MRI-Linac Arm 2 is comparable to the current standard of treatment using conventional CT-based system Arm 1 in terms of local control of the disease at 2 year time point
Hypothesis The investigators would like to hypothesize that breast radiation therapy using MRI-guided system including the MRI-Linac Arm 2 is comparable to the current standard of treatment using conventional CT-based system Arm 1 in terms of local control of the disease at 2 year time point
Detailed Description:
Breast conserving surgery and adjuvant whole breast radiotherapy is a standard treatment option for most patients with early-stage invasive breast cancer Recent technological advances in radiotherapy have enabled shorter treatment courses smaller radiation fields prone positioning and fewer side effects associated with breast cancer treatment To further improve target accuracy in breast radiation delivery an emerging radiotherapy technology takes advantage of on-table MRI imaging and daily adaptive planning during the radiation delivery process
The objectives of the study are to compare side effects in patients treated under either of these treatment settings and to compare recurrence if the cancer comes back rates at a 2-year time point Patients will have annual follow ups up to 10 years and recurrence rates will be measured at 5-year and at 10-year time points
The objectives of the study are to compare side effects in patients treated under either of these treatment settings and to compare recurrence if the cancer comes back rates at a 2-year time point Patients will have annual follow ups up to 10 years and recurrence rates will be measured at 5-year and at 10-year time points
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None