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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01898533

Acronym

BOLD

Enrollment

Registered

2013-07-12

Start date

2013-09-30

Completion date

2014-04-30

Last updated

2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results