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)
1 other identifier
interventional
103
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Mar 2016
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedStudy Start
First participant enrolled
March 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 28, 2022
August 1, 2021
3 years
June 16, 2015
February 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Undergo a CESM
OTHERPatients will undergo an experimental Contrast Enhanced Spectral Mammogram (CESM) in addition to standard diagnostic procedures
Follow Standard care
NO INTERVENTIONPatient will follow standard care pathway.
Interventions
Undergo a Contrast Enhanced Spectral Mammogram in additional to standard of care
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cambridge University Hospitals NHS Foundation Trustlead
- University of Cambridgecollaborator
- GE Healthcarecollaborator
Study Sites (1)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fiona J Gilbert, FRCR
University of Cambridge
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Radiology, Department Head
Study Record Dates
First Submitted
June 16, 2015
First Posted
June 24, 2015
Study Start
March 22, 2016
Primary Completion
March 31, 2019
Study Completion
December 31, 2022
Last Updated
February 28, 2022
Record last verified: 2021-08