Breast CancerCONTENDNCT02479100
Contrast Enhanced Spectral Mammography (CESM) Study
A study testing Contrast Enhanced Spectral Mammogram in people with Breast Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Contrast Enhanced Spectral Mammogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Mar 2016to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: 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.
Read the 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
- Being tested
- Contrast Enhanced Spectral Mammogram
- Keywords
- Contrast Enhanced Spectral Mammography, Breast, Cancer, Diagnosis, Patient management
- Medical subject headings
- Breast Neoplasms, Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced Spectral MammogramDiagnostic test
Undergo a Contrast Enhanced Spectral Mammogram in additional to standard of care
| Study group | Role | What they receive |
|---|---|---|
| Undergo a CESM | Other | Patients will undergo an experimental Contrast Enhanced Spectral Mammogram (CESM) in addition to standard diagnostic procedures Receives: Diagnostic Test: Contrast Enhanced Spectral Mammogram |
| Follow Standard care | No intervention | Patient will follow standard care pathway. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retospective analysis at end of data collection period ( approximately I year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study start22 Mar 2016
- Primary completion31 Mar 2019
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, GE Healthcare
- Responsible party
- Principal investigator, Professor Fiona J Gilbert, University of Cambridge
- Investigators
- Fiona J Gilbert, FRCR, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479100
- Sponsor's protocol ID
- RADIOL/2015/CONTEND
- Acronym
- CONTEND
- Status last verified
- Aug 2021
- First submitted
- 16 Jun 2015
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Impact of CONTrast ENhanceD Mammography (CESM) on Patient Management and Comparison With MRI (CONTEND Study)
- ClinicalTrials.gov ID
- NCT02479100
- Acronym / sponsor ID
- CONTEND / RADIOL/2015/CONTEND
- Conditions
- Breast Cancer
- Keywords
- Contrast Enhanced Spectral Mammography, Breast, Cancer, Diagnosis, Patient management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge, GE Healthcare
- Study start
- 22 Mar 2016 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Undergo a CESM | Other | Diagnostic Test: Contrast Enhanced Spectral MammogramPatients will undergo an experimental Contrast Enhanced Spectral Mammogram (CESM) in addition to standard diagnostic procedures |
| Follow Standard care | No intervention | –Patient will follow standard care pathway. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast Enhanced Spectral MammogramUndergo a Contrast Enhanced Spectral Mammogram in additional to standard of care | Diagnostic test | Undergo a CESM |
Primary outcome
Assessment of impact the addition of CESM has on patient management - does this lead to an earlier diagnosis / treatment plan
Time frame: Retospective analysis at end of data collection period ( approximately I year)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
Related trials for Breast Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Breast Cancer
Not yet recruitingPhase 1
Safety and Biodistribution of [68Ga]Ga DOTA-5G in Subjects With Metastatic Breast Cancer (BC)
Metastatic Breast Cancer
Active, not recruiting
Peer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors
Breast Cancer
RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona J Gilbert, FRCR principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast Enhanced Spectral Mammogram in people with Breast Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of impact the addition of CESM has on patient management - does this lead to an earlier diagnosis / treatment plan (time frame: Retospective analysis at end of data collection period ( approximately I year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.