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

Breast Cancer Clinical Trial

— BOLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898533
• Other study ID #: Pro00046072
• Status: Completed
• Start date: September 2013
• Est. completion date: April 2014

Study information

• Verified date: July 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in BOLD contrast of the breasts and / or chest wall tissue will be measured by comparing breath hold sequences to normal breathing.	Subjects will be evaluated holding their breath and during normal breathing.	During MRI approx 1 hour
Primary	Feasibility as measured by a BOLD contrast signal in at least 30% of subjects	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.	During MRI approx one hour