Cancer Cancer Breast cancer
Conditions
Interventions
All participants receive the equivalent of standard care, a Digital Mammogram (DM) and the experimental procedure which is the Contrast Enhanced Digital Breast Tomosythesis (CE-DBT). Needle biopsy is
Sponsors
University of Dundee and NHS Tayside
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 70 years inclusive 2. Female 3. Able to give informed consent 4. Clinical examination findings suspicious or typical of operable breast cancer (E4/5) AND/OR 5. Ultrasound findings suspicious or typical of malignancy (U4/5) 6. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. History of prior iodinated contrast reaction 2. Iodine allergy 3. Severe asthma 4. Known renal impairment, strong risk factors for renal disease 5. Previous breast cancer surgery or implants 6. Current pregnancy, lactation 7. Inflammatory or clinically obvious locally advanced (inoperable) primary breast cancer who are likely to receive neoadjuvant chemotherapy (in these patients, imaging/pathological correlation will not be possible) 8. Contraindication to MRI 9. Obvious severe comorbidities precluding operative treatment 10. Otherwise deemed to be unsuitable by the clinical team
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of CE-DBT compared with DM using surgical pathology as the gold standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Correlation of tumour size measurements with CE-DBT compared to MRI, using surgical pathology as the gold standard 2. Identification of multifocality with CE-DBT compared to MRI, using surgical pathology as the gold standard 3. Patient perspectives on the CE-DBT procedure is measured using a questionnaire after the procedure 4. Patient perspectives on the MRI scan is measured using a questionnaire after the procedure | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactKulsam Ali
Outcome results
None listed