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 range18 Years

SexFEMALE

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

What they're measuring

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

Feasibility as measured by a BOLD contrast signal in at least 30% of subjects

Timeframe: During MRI approx one hour

Trial details

NCT IDNCT01898533

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-04