Is contrast enhanced spectral mammography (CESM) useful in the investigation of possible abnormalities found on screening mammograms in women with dense breast tissue and does it add useful and important information over and above current standard imaging tests?
- Conditions
- Breast CancerCancer - Breast
- Registration Number
- ACTRN12616000533493
- Lead Sponsor
- Royal Perth Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 69
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity of CESM in comparison to tomosynthesis and/or ultrasound. <br>The assessment of sensitivity is defined as the proportion of index lesions that are malignant on core biopsy or excisional histology that were graded as Tabar score 3, 4, or 5 by the assessment radiologists based on the assessment modality. <br>[First Assessment visit];Specificity of CESM in comparison to tomosynthesis and/or ultrasound.<br>The assessment of specificity is defined as the proportion of index lesions that are not malignant on pathology that are graded as Tabar score 1 or 2 based on the assessment modality.[First Assessment Visit];Number of lesions for which biopsy is felt to be indicated.<br>This is assessed by comparing the radiologists grading of each lesion based on each modality.[First Assessment Visit]
- Secondary Outcome Measures
Name Time Method Radiologists' degree of confidence with which lesions are classified as benign or malignant.<br>The degree of confidence of the radiologist as to the likelihood of the lesion being benign or malignant (Likert 1-5 scale) will also be recorded after each additional investigation.[First Assessment Visit];Requirement for ultrasound.<br>This is assessed by reviewing each modality to see whether ultrasound detected any additional lesions not shown on CESM and also whether ultrasound improved accuracy of lesion etiology. <br>[Within a few days of the initial assessment ];Feasibility of performing CESM during a busy clinic. <br>This will be assessed by monitoring delays or disruptions in the usual clinic work flow. [At the time of first assessment ]