Breast CancerNCT02688257
Assessing Treatment Response in Breast Cancer With Functional Imaging
An observational study of Breast Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
Patients with large primary operable breast cancers are offered chemotherapy prior to surgery to shrink the tumour and enable breast conserving surgery. Conventional assessment of response to chemotherapy relies on a change in tumour size which does not always correlate with the change in amount of viable tumour. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI and Ultrasound
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to 30 Dec 2017
- Phase
- Observational
- 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 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with breast cancer who are due for neoadjuvant chemotherapy
Who may be able to join
- Patients with breast cancer due for neoadjuvant chemotherapy
Who cannot join
- Ferromagnetic implants within body in accordance with standard clinical practice
- claustrophobia
- age <18 or >90
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: Assessing Treatment Response of Breast Cancer Using Multimodal Functional Imaging
Patients with large primary operable breast cancers are offered chemotherapy prior to surgery to shrink the tumour and enable breast conserving surgery. Conventional assessment of response to chemotherapy relies on a change in tumour size which does not always correlate with the change in amount of viable tumour. Newer techniques such as functional MRI, microbubble and optoacoustic ultrasound offer the potential to detect responses to chemotherapy by evaluating functional changes in tumour vascularity and oxygenation. Neither modality utilises ionising radiation.
Although MRI is widely used for detecting breast cancer, its ability in assessing functional responses to chemotherapy prior to surgery has not been fully exploited. Dynamic contrast enhanced (DCE) MRI has a sensitivity around 90% and provides quantitative measurements of blood volume and flow. Other functional techniques detect variation in tissue oxygenation: this is called the blood oxygen level-dependent (BOLD) mechanism. The BOLD technique uses a special magnetic resonance (MR) sequence called T2* to measure the weakly magnetic effect of deoxygenated haemoglobin. The investigators wish to develop and validate T2* measurements which relate to oxygenation of a tumour. The investigators also want to validate other MR sequences including diffusion weighted (DW) MRI, which quantifies microcirculation of blood in the capillary network and the diffusion of water within tissues.
Read more
Microbubble ultrasound is an established technique that utilises an intravenous contrast agent comprising tiny microbubbles of gas that can increase the reflectivity of blood and enhance spectral and colour Doppler signals obtained from routine ultrasound imaging. Optoacoustic imaging is new technique where the output signal depends on the oxygenation of the tissues under study. It utilises a light signal input and measures ultrasound signal output.
The investigators want to correlate our imaging findings with histopathology after surgical resection of the tumour.
- Conditions
- Breast Cancer
- Being tested
- MRI, Ultrasound
- Keywords
- Magnetic Resonance Imaging, Ultrasound, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Functional magnetic resonance imaging
UltrasoundOther
Optoacoustic imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Early and late changes of oxygenation and residual cellularity of patients treated with neoadjuvant chemotherapy, measured using the blood oxygen level dependent (BOLD) technique.
The primary aim of the study is to determine whether specific MRI sequences including dynamic contrast enhanced (DCE) MRI, T2*, diffusion weighted (DW) MRI, as well as microbubble and optoacoustic ultrasound imaging provide early measures of treatment response in breast tumours treated with neoadjuvant chemotherapy.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startSep 2010
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
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.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Principal investigator, NdeSouza, Institute of Cancer Research, United Kingdom
- Investigators
- Nandita DeSouza, Principal investigator, ICR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688257
- Sponsor's protocol ID
- 10/H0806/50 CCR3372
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2016
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Treatment Response of Breast Cancer Using Multimodal Functional Imaging
- ClinicalTrials.gov ID
- NCT02688257
- Acronym / sponsor ID
- 10/H0806/50 CCR3372
- Conditions
- Breast Cancer
- Keywords
- Magnetic Resonance Imaging, Ultrasound, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- Sep 2010 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 23 Feb 2016 (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.
Patients with large primary operable breast cancers are offered chemotherapy prior to surgery to shrink the tumour and enable breast conserving surgery. Conventional assessment of response to chemotherapy relies on a change in tumour size which does not always correlate with the change in amount of viable tumour. Newer techniques such as functional MRI, microbubble and optoacoustic ultrasound offer the potential to detect responses to chemotherapy by evaluating functional changes in tumour vascularity and oxygenation. Neither modality utilises ionising radiation.
Although MRI is widely used for detecting breast cancer, its ability in assessing functional responses to chemotherapy prior to surgery has not been fully exploited. Dynamic contrast enhanced (DCE) MRI has a sensitivity around 90% and provides quantitative measurements of blood volume and flow. Other functional techniques detect variation in tissue oxygenation: this is called the blood oxygen level-dependent (BOLD) mechanism. The BOLD technique uses a special magnetic resonance (MR) sequence called T2* to measure the weakly magnetic effect of deoxygenated haemoglobin. The investigators wish to develop and validate T2* measurements which relate to oxygenation of a tumour. The investigators also want to validate other MR sequences including diffusion weighted (DW) MRI, which quantifies microcirculation of blood in the capillary network and the diffusion of water within tissues.
Microbubble ultrasound is an established technique that utilises an intravenous contrast agent comprising tiny microbubbles of gas that can increase the reflectivity of blood and enhance spectral and colour Doppler signals obtained from routine ultrasound imaging. Optoacoustic imaging is new technique where the output signal depends on the oxygenation of the tissues under study. It utilises a light signal input and measures ultrasound signal output.
The investigators want to correlate our imaging findings with histopathology after surgical resection of the tumour.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer who are due for neoadjuvant chemotherapy
Key inclusion criteria (1 listed)
- Patients with breast cancer due for neoadjuvant chemotherapy
Key exclusion criteria (3 listed)
- Ferromagnetic implants within body in accordance with standard clinical practice
- claustrophobia
- age <18 or >90
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 |
|---|---|---|
| MRIFunctional magnetic resonance imaging | Other | – |
| UltrasoundOptoacoustic imaging | Other | – |
Primary outcome
Early and late changes of oxygenation and residual cellularity of patients treated with neoadjuvant chemotherapy, measured using the blood oxygen level dependent (BOLD) technique.
Time frame: 6 years
The primary aim of the study is to determine whether specific MRI sequences including dynamic contrast enhanced (DCE) MRI, T2*, diffusion weighted (DW) MRI, as well as microbubble and optoacoustic ultrasound imaging provide early measures of treatment response in breast tumours treated with neoadjuvant chemotherapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Nandita DeSouza principal investigator
ICR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Institute of Cancer Research, United Kingdom 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 28 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Early and late changes of oxygenation and residual cellularity of patients treated with neoadjuvant chemotherapy, measured using the blood oxygen level dependent (BOLD) technique. (time frame: 6 years). 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 2018.