To hear about similar clinical trials, please enter your email below
Trial Title:
Magnetic Resonance Imaging in Radiotherapy for Breast Cancer
NCT ID:
NCT05902507
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Imaging
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Magnetic Resonance Imaging Simulation
Description:
Radiographic Image Simulation
Arm group label:
Breast Cancer Participants
Other name:
MRI
Summary:
This is a single-center, prospective pilot study evaluating feasibility and efficacy of
incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation
treatment (RT) for breast cancer.
Detailed description:
PRIMARY OBJECTIVE:
I. To determine feasibility of acquiring MRI simulation prior to RT planning.
EXPLORATORY OBJECTIVE:
I. To determine change in target volume with MRI simulation compared to Computerized
tomography (CT) simulation.
OUTLINE: MRI simulation will be performed once at baseline. There is no follow up planned
for study purposes. Patients will be followed as part of their regular clinical care.
Criteria for eligibility:
Study pop:
Female participants with breast cancer planning to undergo breast conserving surgery
(BCS) and RT outside of this protocol.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Participants with an Eastern Cooperative Oncology Group (ECOG) performance status
<=2 (or Karnofsky ≥>=60%, see Appendix A).
2. Participants with the ability to understand and the willingness to sign a written
informed consent document.
3. Participants may separately enroll on therapeutic clinical trials when they enroll
on this trial. Note: All interventions on this protocol are standard of care, so
enrollment on other therapeutic protocols is allowed at the discretion of the
treating physician.
4. Patients must have pathologically confirmed invasive or in situ breast cancer.
5. Patients must have tumors in which adjuvant breast radiotherapy following breast
conserving surgery is indicated, as determined by the treating physician.
6. Patients must be female. Note: Male patients are excluded due to the rarity of male
breast cancer and difficulty in pursuing breast conserving surgery for male
patients.
Exclusion Criteria:
1. Participants with a contraindication to MRI per the MRI checklist.
2. Patients with breast tumor or tumor bed not visualized at CT or MRI during RT
planning.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Luchia Andemicael
Email:
Luchia.Andemicael@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Lisa Singer, MD, PhD
Email:
Principal Investigator
Start date:
May 15, 2023
Completion date:
May 31, 2025
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05902507
