Breast Cancer
Conditions
Brief summary
This is a pilot study designed to explore the feasibility of non-invasively diagnosing the presence of cancer in the breast using non-invasive magnetic resonance imaging (MRI) methods and an analysis of vessel shape defined from these magnetic resonance images.
Interventions
OTHERMagnetic Resonance Angiography (MRA) of the Breast
Magnetic Resonance Angiography (MRA) of the breast will be performed before or after pre-treatment magnetic resonance imaging (MRI) and then once again before or after the post-treatment MRI.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult women (age \>= 18), * with Histologically documented newly diagnosed stage II-IV invasive breast cancer appropriate for neoadjuvant (preoperative) systemic therapy. * ECOG performance status of 0, 1, or 2 at the initiation of the study.
Exclusion criteria
* pregnant women * women with contralateral mastectomies * known bilateral tumors * subjects prone to claustrophobia * contraindicated to have MRI * mentally impaired * not fluent in english
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Blood Vessel Tortuosity in Breast With Known Cancer | up to two weeks prior to start of chemotheraphy | Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Breast Magnetic Resonance Angiography Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Breast Magnetic Resonance Angiography |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age Continuous | 45.5 years STANDARD_DEVIATION 5.49 |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Amount of Blood Vessel Tortuosity in Breast With Known Cancer
Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy
Time frame: up to two weeks prior to start of chemotheraphy
Population: Blood vessels could not be detected for any of the subjects due to spatial resolution limits of MRI scanner for breast MRI and therefore measurement of blood vessel angularity could not be performed.