None listed
Conditions
Brief summary
The primary purpose of this trial is to investigate the feasibility and efficacy of performing contrast enhanced spectral mammography (CESM) in comparison with the standard of care tests (which are breast tomosynthesis and ultrasound) for the detection of breast cancer in women with dense breast tissue. Who is it for? You may be eligible to participate in this study if you are aged 18 to 65, have dense breast tissue and have been recalled for further investigation of least one non-calcified finding on a screening mammogram. Study details: As part of standard care investigations, all participants enrolled in this trial will undergo tomosynthesis of the breast in which a possible abnormality has been found and an ultrasound scan of both breasts. The tomosynthesis study is a type of mammogram that is able to show the breast tissue slices, As part of this trial, a contrast enhanced spectral mammogram is being tested. This involves the injection of a dye into a vein, followed by two mammogram pictures of each breast taken 2-4 minutes later. The specialised equipment used for the CESM study is able to take mammograms at two different energy levels as well as performing the normal tomosynthesis study. This CESM study is taken at the same time as the tomosynthesis scan and the combined tomosynthesis and CESM study will take about 12 minutes from the start of the injection to completion of the pictures. During this study, the injection will be given first with the participant seated. Two to four minutes later the participant is asked to stand and mammograms of both breasts will be taken with the breasts gently compressed. The tomosynthesis mammograms are taken first, immediately followed by the contrast enhanced mammogram. The tomosynthesis and CESM scans are both taken during the same episode of breast compression ie each breast is only compressed once for each of the views that is taken. Having the CESM scan will mean the breast is compressed for approximately one extra minute longer per view than for a tomosythesis only scan. Researchers will compare the results of the CESM scans to the results from the tomosynthesis and ultrasound scans. Based on all results available, the physician will then make a decision as to whether any further tests, such as a needle biopsy are needed. The treating doctor will be asked to rate their level of confidence in the diagnosis made, and researchers will follow-up to assess whether performing the CESM scan was able to reduce the need for further tests such as needle biopsy and ultrasound. It is hoped that the findings from this trial will provide information on whether CESM may be a useful and feasible tool to aid in the diagnosis of breast cancer in women with dense breasts and help prevent unnecessary extra tests.
Interventions
On arrival the participants have a cannula inserted into a vein and an injection of iodine based contrast (dose of which is dependent on participants' weight. This is usually approximately 100mls of Omnipaque 350 mgI/ml). Following this (approximately 3-5 minutes later) the participant is asked to stand still in front of the x-ray machine whilst images are taken. The entire study takes approximately 10 minutes from the time of the injection. A log of the contrast administered to each partici
On arrival the participants have a cannula inserted into a vein and an injection of iodine based contrast (dose of which is dependent on participants' weight. This is usually approximately 100mls of Omnipaque 350 mgI/ml). Following this (approximately 3-5 minutes later) the participant is asked to stand still in front of the x-ray machine whilst images are taken. The entire study takes approximately 10 minutes from the time of the injection. A log of the contrast administered to each participant will be kept. Contrast Enhanced Spectral Mammography is performed using special equipment that produces high and low energy XRays and is able to logarithmically subtract these images to produce a processed image that shows areas of contrast enhancement within the breast tissue.
Sponsors
Royal Perth Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent 2. Women between the ages of 18 and 65 years with dense breast tissue on their mammograms who have been recalled for further assessment of a non calcified lesion detected on screening mammography 3. Women with one or more non-calcified lesions detected on mammography where tomosynthesis is indicated as part of the assessment investigations. 4. Presence of dense breasts (heterogeneously or extremely dense background parenchymal pattern) on mammography
Exclusion criteria
1. Lesions for which a standard work-up procedure would not include Tomosynthesis 2. Presence of breast prostheses (CESM does not give good images in presence of prostheses) 3. Poor mobility (Participants must be able to stand and be positioned adequately) 4. Pregnancy or lactation 5. Previous reaction to IV iodinated or gadolinium contrast 6. History of multiple allergies requiring medical treatment 7. History of asthma 8. Women unable to give informed consent due to intellectual impairment 9. Women whose primary language is not English whose level of comprehension is believed to be insufficient for them to be able to give written informed consent without a Health Department approved interpreter 10. Poor mobility / physical limitations that would make CESM study impractical to perform 11. Presence of risk factors for or a known history of impaired renal function (as identified using the IV contrast administration guidelines) 12. Age over 65 13. Diabetic 14. Thyroid disease: Untreated hyperthyroidism or presence of a known hyperfunctioning thyroid nodule. Patients scheduled to undergo diagnostic or therapeutic procedures involving radioisotope scanning of the thyroid (including thyroid cancer treatment) (radioisotope uptake will be prevented for 8 weeks following iodinated contrast administration). 15. History of Myasthenia Gravis 16. Women who are taking Beta Blocking medication 17. Women who are being treated with Interleukin-2
Outcome results
None listed