Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
When patients present with breast symptoms they are usually referred by their general practitioners for assessment in a one-stop breast clinic. At the clinic, they will undergo clinical assessment by
Sponsors
Darlington Memorial Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 years or over 2. Have undergone ultrasound scanning and/ or mammography for their current breast cancer diagnosis 3. Have pathologically documented primary invasive breast carcinoma 4. Be suitable for axillary surgery 5. Be able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Are medically unstable as judged by the Chief Investigator or Trial Nurse 2. Are known to have had an allergic reaction associated with previous administration of iodinated contrast agent or have a severe allergic diathesis 3. Require renal dialysis 4. Have had previous surgery or radiotherapy for cancer to the ipsilateral (same side) axilla 5. Pregnant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the rate of re-operation on the axilla when comparing CT-informed and routine care. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient satisfaction (as evidenced by patient satisfaction questionnaires) at 2 weeks post surgery 2. The sensitivity, specificity, and positive and negative predictive values of ultrasound of the axilla, ultrasound with needle sampling and mulidetector CT 3. Economic analysis 4. Rates of common post surgical complications in both groups including wound infections, serous axillary collections, and lymphoedema | — |
Countries
United Kingdom
Outcome results
None listed