Contrast Enhanced Spectral Mammography (CESM) Study

NCT ID: NCT02479100

Last Updated: 2022-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-22
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Undergo a CESM

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

Group Type: OTHER

Contrast Enhanced Spectral Mammogram

Intervention Type: DIAGNOSTIC_TEST

Undergo a Contrast Enhanced Spectral Mammogram in additional to standard of care

Follow Standard care

Patient will follow standard care pathway.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Contrast Enhanced Spectral Mammogram

Undergo a Contrast Enhanced Spectral Mammogram in additional to standard of care

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Cambridge

OTHER

Sponsor Role: collaborator

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Professor Fiona J Gilbert

Professor of Radiology, Department Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fiona J Gilbert, FRCR

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Locations

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

RADIOL/2015/CONTEND

Identifier Type: -

Identifier Source: org_study_id