Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- 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
- description
- Subjects will be evaluated holding their breath and during normal breathing.
- measure
- Feasibility as measured by a BOLD contrast signal in at least 30% of subjects
- timeFrame
- During MRI approx one hour
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available