Clinical trial · Interventional
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)
NCT02479100CI-TRIAL-00056791CONTENDunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast Enhanced Spectral Mammogram | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Undergo a CESM
- description
- Patients will undergo an experimental Contrast Enhanced Spectral Mammogram (CESM) in addition to standard diagnostic procedures
- interventionNames
- Diagnostic Test: Contrast Enhanced Spectral Mammogram
- type
- NO_INTERVENTION
- label
- Follow Standard care
- description
- Patient will follow standard care pathway.
Primary outcomes (1)
- measure
- Assessment of impact the addition of CESM has on patient management - does this lead to an earlier diagnosis / treatment plan
- timeFrame
- Retospective analysis at end of data collection period ( approximately I year)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.