Comparative evaluation of Contrast Enhanced Spectral Mammography (CESM) and Contrast Enhanced Magnetic Resonance Imaging (CEMRI) for local staging of breast cancer: the CESM V study

Not Applicable

Not yet recruiting

• Conditions: ocal staging of primary breast cancer; Local staging of primary breast cancer; Cancer - Breast

• Registration Number: ACTRN12613000684729
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-21
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Female of any race or ethnicity.
-Aged 35 years and over.
-Core biopsy proven diagnosis of invasive breast cancer in one or both breasts.
-Participant fit to undergo surgical treatment, either breast conservation surgery or mastectomy.

Exclusion Criteria

-Male.
-Unable or unwilling to give informed consent.
-Impaired mobility (good mobility is needed to ensure the CESM can be performed within the required time after the contrast injection is given).
-Presence of breast implants.
-Pregnancy or breast feeding.
-A participant who is not fit for or declines surgical treatment.
-participant who is going to have neoadjuvant chemotherapy
-The breast lesion consists solely of in-situ” carcinoma on core biopsy histology.
-Contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent, particularly renal insufficiency or allergy.
-Known contraindication to MRI examination, e.g. metallic implant, aneurysm clip

Study & Design

• Study Type: Interventional
• Study Design: Not specified