None listed
Conditions
Brief summary
This study aims to evaluate the accuracy of an imaging technique called contrast enhanced spectral mammography (CESM) for assessing the extent of Ductal Carcinoma in Situ (DCIS). Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with ductal carcinoma in situ (DCIS), a non-invasive form of breast cancer where abnormal cells are contained within the milk ducts, on core biopsy, for which you are undergoing pre-surgical assessment at Royal Perth Hospital in Western Australia. Study details All participants in this study will undergo contrast enhanced spectral mammography (CESM) in addition to standard imaging and histopathology. CESM is a special type of mammogram performed after injection of intravenous x-ray dye (contrast). The CESM images will be independently read by two radiologists, and compared to standard imaging. If there are additional findings on the CESM images, these may be used to change subsequent surgical treatment. All participants will be followed up 12 months following their treatment as per standard of care for patients who have had breast conserving surgery. Cost effectiveness of the addition of CESM to standard imaging will also be evaluated. It is hoped that CESM will be more accurate than standard imaging at demonstrating the extent of DCIS – this may improve surgical planning and reduce the need for re-excision.
Interventions
Women with a biopsy-confirmed diagnosis of ductal carcinoma in situ (DCIS) will be identified in the Breast Clinic at Perth Royal Hospital.
Women who give written, informed consent and who meet the eligibility criteria for the study will be given an appointment for Contrast Enhanced Spectral Mammography (CESM).
For the CESM study, an intravenous cannula will be inserted by a trained staff member and an injection of non-ionic iodinated contrast (1.5mg/kg delivering 350mg/ml up to a maximum of 12
Women with a biopsy-confirmed diagnosis of ductal carcinoma in situ (DCIS) will be identified in the Breast Clinic at Perth Royal Hospital. Women who give written, informed consent and who meet the eligibility criteria for the study will be given an appointment for Contrast Enhanced Spectral Mammography (CESM). For the CESM study, an intravenous cannula will be inserted by a trained staff member and an injection of non-ionic iodinated contrast (1.5mg/kg delivering 350mg/ml up to a maximum of 125ml) will be given using a power injector at a rate of 3ml/s. Two minutes later, standard mammographic views (CC and MLO of both breasts) will be performed using dual-energy exposures. Additional views may be obtained if necessary. The CESM study will be independently read by two radiologists on standardised case report forms according to modified Breast Imaging Reporting and Data System (BI-RADS) MR descriptors. If the CESM does not show any significant additional findings that would change the recommended treatment plan, no further investigations will be needed prior to the routine surgical appointment. Further assessment will be performed if there are additional findings based on the CESM which could change recommended management if confirmed to be malignant and may include targeted ultrasound (US), additional mammographic views and breast MRI. If there are additional findings that cannot be downgraded to a NBCC 2 or below (i.e. benign) on further work-up and if determination of the underlying pathology will change treatment, core needle biopsy or preoperative image guided localisation for open biopsy will be performed after multidisciplinary discussion. In instances where biopsy is not possible or biopsy result is benign or inconclusive, follow-up breast imaging at six to twelve months post treatment using the most appropriate modality will be the default recommendation. If all further imaging is negative (US, mammogram and CEMRI), surgical planning will proceed as per findings on standard of care imaging with routine annual follow-up mammography. Wherever possible all additional imaging prompted by the CESM study will be performed within the usual time frame between diagnosis and the surgical planning appointment for patients seen in the public system (2 weeks). Surgeons will be asked to complete a questionnaire documenting if / how the findings on CESM influenced the surgical plan recommended to the participant. As per standard of care for patients who have had breast conserving surgery, all participants will have a routine cancer follow-up mammogram 12 months following their treatment.
Sponsors
Clin. Assoc. Prof. Donna Taylor
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a. Able to give written informed consent b. Women with one or more pure ductal carcinoma in situ (DCIS) lesion(s) on core biopsy c. Women who are over the ages of 18 at diagnosis d. Women undergoing assessment at Royal Perth Hospital, WA
Exclusion criteria
a. Inability to give written informed consent (women whose English comprehension is such that they are considered unable to give informed consent will be excluded) b. Evidence of invasive disease within the subject focus of DCIS c. Women who decline or are unfit to have breast surgery d. Women who are pregnant or lactating. e. Contraindications for CESM including i. Previous reaction to contrast media or allergic reaction requiring medical attention ii. Known renal disease (including renal transplant) iii. Diabetes Mellitus (including any patient taking metformin) iv. Poorly controlled asthma v. Known or suspected thyrotoxicosis vi. Patients who are to undergo diagnostic or therapeutic procedures involving radioisotope scanning of the thyroid within 8 weeks of CESM. vii. Known Myasthenia graves viii. Previous administration of IV contrast within 24hours f. Presence of breast implants g. Limited mobility such that the CESM study cannot be completed within 10 minutes of contrast injection
Outcome results
None listed