Contrast Enhanced Spectral Mammography (CESM) Study (CONTEND)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: Contrast Enhanced Spectral Mammogram

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Cambridge University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Undergo a CESM; Patients will undergo an experimental Contrast Enhanced Spectral Mammogram (CESM) in addition to standard diagnostic procedures	Diagnostic test: Contrast Enhanced Spectral Mammogram; Undergo a Contrast Enhanced Spectral Mammogram in additional to standard of care
No Intervention: Follow Standard care; Patient will follow standard care pathway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of impact the addition of CESM has on patient management - does this lead to an earlier diagnosis / treatment plan	The pathway of each participant through the diagnostic process will be reviewed at the end of the data collection period to assess whether the addition of CESM resulted in a definitive decision regarding treatment being made earlier than in the usual diagnostic route.	Retospective analysis at end of data collection period ( approximately I year)

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: GE Healthcare; University of Cambridge
• Investigators: Principal Investigator: Fiona J Gilbert, FRCR, University of Cambridge

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2016
• Primary Completion (Actual): March 31, 2019
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 16, 2015
• First Submitted That Met QC Criteria: June 17, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Diagnosis; Breast; Patient management; Contrast Enhanced Spectral Mammography
• Other Study ID Numbers: RADIOL/2015/CONTEND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No