Breast cancer Cancer
Conditions
Interventions
This is a paired comparison study of a diagnostic test (CEM) i.e. all participants will receive the equivalent of standard care (MRI) plus the experimental procedure. CEM is considered to be the inter
before chemotherapy, and after finishing chemotherapy. As it may not be possible to arrange the CEM studies on the same day as the MRI, it is possible the participants will need to attend the hospital
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Individuals (aged 18 years and above) with invasive breast cancer 2. Willing and able to give informed consent 3. Requiring imaging monitoring of response to NACT 4. Undergoing standard-of-care monitoring with breast MRI 5. Symptomatic or screen-detected breast cancer
Exclusion criteria
Exclusion criteria: 1. Contraindication to CEM contrast agent (iodine) 2. Unwilling to have CEM 3. Ipsilateral breast implant 4. Pregnant or breastfeeding 5. Radiotherapy prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute differences between tumour size measurements from each imaging technique and surgical pathology. Maximum imaging lesion size will be recorded on CEM (enhancement + microcalcification) and MRI, as described above. Pathological size will be defined as whole tumour size (WTS). Timepoint: Post surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absolute differences between tumour size measurements from each imaging technique and WTS, where CEM size is the extent of enhancement only. Timepoint: Post-surgery. 2. Absolute differences between tumour size measurements from each imaging technique and WTS, where CEM size is the extent of enhancement only. Timepoint: Post-surgery. 3. Absolute differences between tumour size measurements from each imaging technique and ITS, where CEM size is the extent of enhancement only. Timepoint: Post-surgery. 4. Signed difference between tumour size measurements from each imaging technique and surgical pathology. Timepoint: Post-surgery. 5. Absolute differences between tumour size measurements from each imaging technique and WTS and ITS, where MRI enhancement size is combined with the extent of microcalcification on the LE component of the CEM. Timepoint: Post-surgery. 6. Accuracy, specificity and sensitivity of CEM (enhancement only) and MRI for determining pCR. Timepoint: Post-surgery. 7. Accuracy, specificity and sensitivity of CEM (enhancement + microcalcifications) and MRI for determining pCR. Timepoint: Post-surgery. 8. Diagnostic accuracy of the pre-treatment imaging for identifying multifocality will be assessed by correlation with biopsy results. A true positive is defined as an additional lesion identified by CEM and/or MRI, demonstrated to be malignant on core biopsy. A true negative is unifocal disease on imaging confirmed at surgery. A false positive is an additional suspicious lesion identified on CEM and/or MRI proven benign on pathology. A false negative is when imaging indicates unifocal disease but additional foci of malignancy are proven pathologically. Timepoint: post-biopsy (pre-NACT). 9. Diagnostic accuracy of the pre-treatment imaging for identifying multifocality will be assessed by correlation with biopsy results. Timepoint: post-biopsy (pre-NACT). 10. Patient acceptability will be assessed after completion of both imaging techniques using a special | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactLyn Mitchell
Outcome results
None listed