NCT02479100

Contrast Enhanced Spectral Mammography (CESM) Study

An Assessment of the Impact of CONTrast ENhanceD Mammography (CESM) on Patient Management and Comparison With MRI (CONTEND Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine if the addition of Contrast Enhanced Spectral Mammography (CESM) to standard diagnostic imaging, results in a decision regarding patient management - discharge, follow-up, surgery or treatment - being made sooner than it would if the patient had followed the standard course of investigations and review.

Detailed description

Women with suspicious breast lesions following mammography and ultrasound will be eligible for the study. Those who consent to participate will be randomised either to receive Contrast Enhanced Spectral Mammography (CESM) in addition to standard care or to receive standard care alone. Women randomised to receive CESM will undergo the procedure either during the same visit or if necessary on another date within a week. Any additional suspicious lesions detected by CESM will be biopsied along with the original lesion either under ultrasound or x-ray guidance. Biopsy of suspicious lesions is standard care and not part of the research protocol. Those randomised to receive standard care will undergo ultrasound or x-ray guided biopsy of any suspicious lesion identified by ultrasound or mammography. Results of all biopsies will be discussed at the next multidisciplinary (MDT) meeting where a treatment decision (conservation surgery, mastectomy or neoadjuvent therapy) will be made for those with confirmed disease. MRI will be performed on appropriate women in line with standard practice. Additional disease detected by MRI will be biopsied, either under ultrasound or MRI guidance, if this will influence patient management. The results from these cases will be discussed at the next MDT meeting. For those women in either arm of the study with benign biopsy results standard care will be followed. A proforma will be used to record patient pathway, biopsy results and MDT patient management decisions for each case. For women who received both CESM and MRI, a retrospective review of these images will be made in order to compare diagnostic accuracy. Images from each imaging modality will be read by a different reader for each case. CESM images will be read without the knowledge of MRI results and vice versa. A proforma will be completed by readers to record findings.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Contrast Enhanced Spectral Mammogram	Undergo a Contrast Enhanced Spectral Mammogram in additional to standard of care

Timeline

• Start date: 2016-03-22
• Primary completion: 2019-03-31
• Completion: 2022-12-31
• First posted: 2015-06-24
• Last updated: 2022-02-28

Locations

1 site across 1 country: United Kingdom