None listed
Conditions
Brief summary
Contrast Enhanced Magnetic Resonance Imaging (CEMRI) of the breast is the most accurate imaging test to show the size and extent of breast cancer. A new technique, Contrast Enhanced Spectral Mammography (CESM) is also capable of showing areas of abnormal blood flow in the breast that are associated with breast cancer, similar to the way in which contrast enhanced breast MRI works. Due to limited availability and cost, CEMRI is not routinely used to assess all breast cancers in Australia; rather its use is reserved to answer specific questions. Whilst approved for use in Australia by the Therapeutic Goods Administration (TGA), CESM is not routinely used for breast cancer assessment as its role in planning treatment is not yet clear. This study aims to see whether this new technique is as effective as CEMRI in showing the full extent of cancer in the breast - a finding that has been suggested in other studies of CESM. We hope that proof of this will allow more accurate assessment of women with potential cancerous areas in their breasts without the need for CEMRI, which is not suitable for everyone and not widely available due to cost and limited access to MRI machines.
Interventions
CESM is carried out on commercially available equipment approved for diagnostic use in Australia, a device (Senographe DS - GE Healthcare Australia, Rydalmere, NSW) which is capable of delivering dual energy x-rays in quick succession, with both a normal low Kvp and a higher energy (45-50kVp) exposure. An injection of non-ionic iodinated contrast (1.5mg/kg delivering 350mg I/mL) is given via a catheter in an antecubital vein using a power injector at a rate of 3mL/s. Two minutes later, standard
CESM is carried out on commercially available equipment approved for diagnostic use in Australia, a device (Senographe DS - GE Healthcare Australia, Rydalmere, NSW) which is capable of delivering dual energy x-rays in quick succession, with both a normal low Kvp and a higher energy (45-50kVp) exposure. An injection of non-ionic iodinated contrast (1.5mg/kg delivering 350mg I/mL) is given via a catheter in an antecubital vein using a power injector at a rate of 3mL/s. Two minutes later, standard mammographic views (CC and MLO of both breasts) are performed with dual-energy exposures. All four views are obtained within 4 minutes of the injection. The high energy and low energy exposures are subtracted from one another taking advantage of the K-edge of iodine producing images which demonstrate areas of contrast enhancement. The extra exposure is associated with minor increase in radiation dose to the breast of 20% per image.
Sponsors
Royal Perth Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-Female of any race or ethnicity. -Aged 35 years and over. -Core biopsy proven diagnosis of invasive breast cancer in one or both breasts. -Participant fit to undergo surgical treatment, either breast conservation surgery or mastectomy.
Exclusion criteria
-Male. -Unable or unwilling to give informed consent. -Impaired mobility (good mobility is needed to ensure the CESM can be performed within the required time after the contrast injection is given). -Presence of breast implants. -Pregnancy or breast feeding. -A participant who is not fit for or declines surgical treatment. -participant who is going to have neoadjuvant chemotherapy -The breast lesion consists solely of “in-situ” carcinoma on core biopsy histology. -Contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent, particularly renal insufficiency or allergy. -Known contraindication to MRI examination, e.g. metallic implant, aneurysm clip
Outcome results
None listed