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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01898533
• Lead Sponsor: Duke University

Brief 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

Detailed Description

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

Study Timeline

• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-12
• Study Start: 2013-09
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in BOLD contrast of the breasts and / or chest wall tissue will be measured by comparing breath hold sequences to normal breathing.	During MRI approx 1 hour	Subjects will be evaluated holding their breath and during normal breathing.
Feasibility as measured by a BOLD contrast signal in at least 30% of subjects	During MRI approx one hour	The imaging technique will be considered feasible if for any of the proposed imaging sequences, breath-holding induces a measurable (≥3× standard deviation of background) BOLD contrast signal in at least 30% of the subjects. Contrast will be measured by comparing breath hold sequences to normal breathing.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States