Feasibility of Blood Oxygenation Level-Dependent Contrast (BOLD) Breast MRI Induced by Breath- Ho… (NCT01898533) | Clinical Trial Compass
CompletedNot Applicable
Feasibility of Blood Oxygenation Level-Dependent Contrast (BOLD) Breast MRI Induced by Breath- Holding
United States11 participantsStarted 2013-09
Plain-language summary
In this study, investigators intend to measure changes in BOLD contrast in the breast induced by breath-holding for subjects receiving radiation therapy to the breast. This study will provide the preliminary data and experience needed to successfully apply BOLD to quantify changes in oxygenation and blood flow of breast and tumor for a larger cohort of breast radiotherapy patients. The current study has the following objectives:
1. To determine the feasibility of BOLD contrast MRI of the breast, induced by breath-hold.
2. To measure the change in BOLD contrast of the breast and / or chest wall tissue for females undergoing radiotherapy
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: • Post-operative patients who are undergoing planning for future whole breast radiation therapy may be included in the study
* Female
* Age ≥18
* Negative serum pregnancy test for women of child bearing potential
* Signed study-specific informed consent
Exclusion Criteria:
* Unable to perform breath-holding of adequate duration.
* Unable to lie prone for approximately one hour during the study procedure
* Breast implants
* Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc.
* Positive serum pregnancy test
* Mastectomy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change in BOLD contrast of the breasts and / or chest wall tissue will be measured by comparing breath hold sequences to normal breathing.
Timeframe: During MRI approx 1 hour
2
Feasibility as measured by a BOLD contrast signal in at least 30% of subjects