Feasibility of Blood Oxygenation Level-Dependent Contrast (BOLD) Breast MRI Induced by Breath- Holding

Duke University

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01898533

Pro00046072

Details and patient eligibility

About

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

Full description

11 subjects were consented to the trial. One subject voluntarily withdrew before any study procedures were performed.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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