Contrast Enhanced Spectral Mammography (CESM) Study (CONTEND)

NHS Foundation Trust

Status: Unknown

Conditions: Breast Cancer

Treatments: Diagnostic Test: Contrast Enhanced Spectral Mammogram

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02479100

RADIOL/2015/CONTEND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be willing and able to give written informed consent for participation in the study.
• Have a lesion of suspicion 3, 4 or 5 following mammography and ultrasound.

Exclusion criteria

• Known or suspected pregnancyBreast implant
• Previous breast cancer
• Known renal impairment
• History of anaphylactoid or anaphylactic reaction to any contrast media
• Contrast media within 24 hours prior to CESM
• Commencement of neo-adjuvant chemotherapy, hormone treatment, radiotherapy or surgery for this episode

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Undergo a CESM

Other group

Description:

Patients will undergo an experimental Contrast Enhanced Spectral Mammogram (CESM) in addition to standard diagnostic procedures

Treatment:

Diagnostic Test: Contrast Enhanced Spectral Mammogram

Follow Standard care

No Intervention group

Description:

Patient will follow standard care pathway.