Breast CancerNCT02798484
Monitoring of Breast Cancers Treated by Neoadjuvant Therapy Via Diffusion-weighted Magnetic Resonance Imaging
A study testing Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI) in people with Breast Cancer, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Magnetic resonance imaging (MRI) is the method of choice in breast cancer to perform the loco-regional staging and direct the treatment. European Guidelines (EUSOMA) currently recommend MRI for initial evaluation and assessement of the neoadjuvant chemotherapy (NAC) response, for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Jun 2016to 31 Jan 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer
- Neo-adjuvant therapy indication
- Performance status from 0 to 2
Who cannot join
- Contraindications to magnetic resonance imaging (pacemaker, nerve stimulator, cochlear implant, major claustrophobia)
- Absence of histological results
- Disruption of the neo-adjuvant therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: Monitoring of Breast Cancers Treated by Neoadjuvant Therapy Via Diffusion-weighted Magnetic Resonance Imaging
Magnetic resonance imaging (MRI) is the method of choice in breast cancer to perform the loco-regional staging and direct the treatment.
European Guidelines (EUSOMA) currently recommend MRI for initial evaluation and assessement of the neoadjuvant chemotherapy (NAC) response, for breast cancer. The standard of care consists of realizing a MRI before the start of the NAC and another one after it's ended, six months later.
Read more
There is currently no consensus on the realization of an interval MRI for early assessment of the chemosensitivity of the tumor. It would allow though alterations in the therapeutic regimen in the event of a non response. Similarly, there is no consensus on when this interval MRI should be performed.
Some recent studies suggest that Diffusion-weighted Magnetic Resonance Imaging is interesting for the evaluation of the early response. However, these are preliminary studies with quantitative measures realized by the region of interest (ROI) method. A response to neoadjuvant chemotherapy results in elevated values of apparent diffusion coefficients (ADC).
The investigator's goal for this study is to evaluate the reliability of diffusion as tumor biomarker. Therefore, they will study the quantitative analysis of the diffusion-weighted magnetic resonance sequences in the pre-therapeutic assessment and the early and late follow-up of breast cancers under neoadjuvant treatment (chemotherapy, hormonotherapy...) within the CHU Brugmann hospital. The results of this analysis will be compared with the MRI results obtained at the end of the treatment and with the histology of the initial biopsy and the surgical specimen.
The expected benefits are:
- to establish correlations between apparent diffusion coefficients (ADC) values and histology
- to observe changes in the ADC according to the type of response: ADC increase in the event of partial response, ADC stability in the event of non response, ADC decrease in the event of a progression, absence of restriction in the event of a complete response.
- to confirm that diffusion weighted MRI within a short interval (after one cure, at one month) has a predictive value for the neoadjuvant chemotherapy (NAC) response.
- Conditions
- Breast Cancer
- Being tested
- Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI)
- Keywords
- Diffusion Weighted Magnetic Resonance Imaging, Breast cancer, Neo-adjuvant therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI)Device
MRI examinations performed on two devices: Ingernia 3 Testla (Philips) on the Horta site of the CHU Brugmann hospital, and Area 1,5 Tesla (Siemens) on the Brien site of the CHU Brugmann hospital. Diffusion sequences last 6 minutes and are already performed in the standard of care. Compared to the standard of care, one additional MRI will be performed one month after the start of the neo-adjuvant treatment, with diffusion analysis.The post-processing of the examinations will be realized with the Syngo Onco Care application of Siemens.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | Experimental | Patients diagnosed with breast cancer and placed under neo-adjuvant treatment (hormonotherapy, chemotherapy) within the CHU Brugmann hospital. Receives: Device: Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparent diffusion coefficient (ADC) (mm2/sec)
Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
Measured: Baseline: start of the neo-adjuvant therapy
Apparent diffusion coefficient (ADC) (mm2/sec)
Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
Measured: One month after the start of the neo-adjuvant therapy
Apparent diffusion coefficient (ADC) (mm2/sec)
Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
Measured: At the end of the neo-adjuvant therapy (typical duration: 6 months)
Anatomo-pathology classification - histological type
The histological type of the tumor will be determined by the Anatomo-Pathology Department of the CHU Brugmann hospital, according to standard of care. The determination will be performed on the initial biopsy samples used for diagnosis and/or on the surgical specimen.
Measured: Baseline: start of the neo-adjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start21 Jun 2016
- Primary completion1 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mieke Cannie, Brugmann University Hospital
- Investigators
- Mieke Cannie, MD, Principal investigator, CHU BrugmannNathalie Hottat, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798484
- Sponsor's protocol ID
- CHUB-CNA
- Status last verified
- Jan 2020
- First submitted
- 9 Jun 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Fiorentino C, Berruti A, Bottini A, Bodini M, Brizzi MP, Brunelli A, Marini U, Allevi G, Aguggini S, Tira A, Alquati P, Olivetti L, Dogliotti L. Accuracy of mammography and echography versus clinical palpation in the assessment of response to primary chemotherapy in breast cancer patients with operable disease. Breast Cancer Res Treat. 2001 Sep;69(2):143-51. doi: 10.1023/a:1012277325168.
PubMed 11759820Vinnicombe SJ, MacVicar AD, Guy RL, Sloane JP, Powles TJ, Knee G, Husband JE. Primary breast cancer: mammographic changes after neoadjuvant chemotherapy, with pathologic correlation. Radiology. 1996 Feb;198(2):333-40. doi: 10.1148/radiology.198.2.8596827.
PubMed 8596827Huber S, Wagner M, Zuna I, Medl M, Czembirek H, Delorme S. Locally advanced breast carcinoma: evaluation of mammography in the prediction of residual disease after induction chemotherapy. Anticancer Res. 2000 Jan-Feb;20(1B):553-8.
PubMed 10769724Balu-Maestro C, Chapellier C, Bleuse A, Chanalet I, Chauvel C, Largillier R. Imaging in evaluation of response to neoadjuvant breast cancer treatment benefits of MRI. Breast Cancer Res Treat. 2002 Mar;72(2):145-52. doi: 10.1023/a:1014856713942.
PubMed 12038705Sardanelli F, Boetes C, Borisch B, Decker T, Federico M, Gilbert FJ, Helbich T, Heywang-Kobrunner SH, Kaiser WA, Kerin MJ, Mansel RE, Marotti L, Martincich L, Mauriac L, Meijers-Heijboer H, Orecchia R, Panizza P, Ponti A, Purushotham AD, Regitnig P, Del Turco MR, Thibault F, Wilson R. Magnetic resonance imaging of the breast: recommendations from the EUSOMA working group. Eur J Cancer. 2010 May;46(8):1296-316. doi: 10.1016/j.ejca.2010.02.015. Epub 2010 Mar 19.
PubMed 20304629Wu LM, Hu JN, Gu HY, Hua J, Chen J, Xu JR. Can diffusion-weighted MR imaging and contrast-enhanced MR imaging precisely evaluate and predict pathological response to neoadjuvant chemotherapy in patients with breast cancer? Breast Cancer Res Treat. 2012 Aug;135(1):17-28. doi: 10.1007/s10549-012-2033-5. Epub 2012 Apr 4.
PubMed 22476850Li XR, Cheng LQ, Liu M, Zhang YJ, Wang JD, Zhang AL, Song X, Li J, Zheng YQ, Liu L. DW-MRI ADC values can predict treatment response in patients with locally advanced breast cancer undergoing neoadjuvant chemotherapy. Med Oncol. 2012 Jun;29(2):425-31. doi: 10.1007/s12032-011-9842-y. Epub 2011 Feb 1.
PubMed 21286861Just N. Improving tumour heterogeneity MRI assessment with histograms. Br J Cancer. 2014 Dec 9;111(12):2205-13. doi: 10.1038/bjc.2014.512. Epub 2014 Sep 30.
PubMed 25268373Hottat NA, Badr DA, Lecomte S, Besse-Hammer T, Jani JC, Cannie MM. Assessment of diffusion-weighted MRI in predicting response to neoadjuvant chemotherapy in breast cancer patients. Sci Rep. 2023 Jan 12;13(1):614. doi: 10.1038/s41598-023-27787-x.
PubMed 36635514
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Monitoring of Breast Cancers Treated by Neoadjuvant Therapy Via Diffusion-weighted Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02798484
- Acronym / sponsor ID
- CHUB-CNA
- Conditions
- Breast Cancer
- Keywords
- Diffusion Weighted Magnetic Resonance Imaging, Breast cancer, Neo-adjuvant therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 14 Jun 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.
Magnetic resonance imaging (MRI) is the method of choice in breast cancer to perform the loco-regional staging and direct the treatment.
European Guidelines (EUSOMA) currently recommend MRI for initial evaluation and assessement of the neoadjuvant chemotherapy (NAC) response, for breast cancer. The standard of care consists of realizing a MRI before the start of the NAC and another one after it's ended, six months later.
There is currently no consensus on the realization of an interval MRI for early assessment of the chemosensitivity of the tumor. It would allow though alterations in the therapeutic regimen in the event of a non response. Similarly, there is no consensus on when this interval MRI should be performed.
Some recent studies suggest that Diffusion-weighted Magnetic Resonance Imaging is interesting for the evaluation of the early response. However, these are preliminary studies with quantitative measures realized by the region of interest (ROI) method. A response to neoadjuvant chemotherapy results in elevated values of apparent diffusion coefficients (ADC).
The investigator's goal for this study is to evaluate the reliability of diffusion as tumor biomarker. Therefore, they will study the quantitative analysis of the diffusion-weighted magnetic resonance sequences in the pre-therapeutic assessment and the early and late follow-up of breast cancers under neoadjuvant treatment (chemotherapy, hormonotherapy...) within the CHU Brugmann hospital. The results of this analysis will be compared with the MRI results obtained at the end of the treatment and with the histology of the initial biopsy and the surgical specimen.
The expected benefits are:
- to establish correlations between apparent diffusion coefficients (ADC) values and histology
- to observe changes in the ADC according to the type of response: ADC increase in the event of partial response, ADC stability in the event of non response, ADC decrease in the event of a progression, absence of restriction in the event of a complete response.
- to confirm that diffusion weighted MRI within a short interval (after one cure, at one month) has a predictive value for the neoadjuvant chemotherapy (NAC) response.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | Experimental | Device: Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI)Patients diagnosed with breast cancer and placed under neo-adjuvant treatment (hormonotherapy, chemotherapy) within the CHU Brugmann hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Breast cancer
- Neo-adjuvant therapy indication
- Performance status from 0 to 2
Key exclusion criteria (3 listed)
- Contraindications to magnetic resonance imaging (pacemaker, nerve stimulator, cochlear implant, major claustrophobia)
- Absence of histological results
- Disruption of the neo-adjuvant therapy
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 |
|---|---|---|
| Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI)MRI examinations performed on two devices: Ingernia 3 Testla (Philips) on the Horta site of the CHU Brugmann hospital, and Area 1,5 Tesla (Siemens) on the Brien site of the CHU Brugmann hospital. Diffusion sequences last 6 minutes and are already performed in the standard of care. Compared to the standard of care, one additional MRI will be performed one month after the start of the neo-adjuvant treatment, with diffusion analysis.The post-processing of the examinations will be realized with the Syngo Onco Care application of Siemens. | Device | Breast cancer |
Primary outcome
Apparent diffusion coefficient (ADC) (mm2/sec)
Time frame: Baseline: start of the neo-adjuvant therapy
Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
Apparent diffusion coefficient (ADC) (mm2/sec)
Time frame: One month after the start of the neo-adjuvant therapy
Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
Apparent diffusion coefficient (ADC) (mm2/sec)
Time frame: At the end of the neo-adjuvant therapy (typical duration: 6 months)
Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
Anatomo-pathology classification - histological type
Time frame: Baseline: start of the neo-adjuvant therapy
The histological type of the tumor will be determined by the Anatomo-Pathology Department of the CHU Brugmann hospital, according to standard of care. The determination will be performed on the initial biopsy samples used for diagnosis and/or on the surgical specimen.
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 18 Jan 2020.
- Background: PubMed 11759820Fiorentino C, Berruti A, Bottini A, Bodini M, Brizzi MP, Brunelli A, Marini U, Allevi G, Aguggini S, Tira A, Alquati P, Olivetti L, Dogliotti L. Accuracy of mammography and echography versus clinical palpation in the assessment of response to primary chemotherapy in breast cancer patients with operable disease. Breast Cancer Res Treat. 2001 Sep;69(2):143-51. doi: 10.1023/a:1012277325168.
- Background: PubMed 8596827Vinnicombe SJ, MacVicar AD, Guy RL, Sloane JP, Powles TJ, Knee G, Husband JE. Primary breast cancer: mammographic changes after neoadjuvant chemotherapy, with pathologic correlation. Radiology. 1996 Feb;198(2):333-40. doi: 10.1148/radiology.198.2.8596827.
- Background: PubMed 10769724Huber S, Wagner M, Zuna I, Medl M, Czembirek H, Delorme S. Locally advanced breast carcinoma: evaluation of mammography in the prediction of residual disease after induction chemotherapy. Anticancer Res. 2000 Jan-Feb;20(1B):553-8.
- Background: PubMed 12038705Balu-Maestro C, Chapellier C, Bleuse A, Chanalet I, Chauvel C, Largillier R. Imaging in evaluation of response to neoadjuvant breast cancer treatment benefits of MRI. Breast Cancer Res Treat. 2002 Mar;72(2):145-52. doi: 10.1023/a:1014856713942.
- Background: PubMed 20304629Sardanelli F, Boetes C, Borisch B, Decker T, Federico M, Gilbert FJ, Helbich T, Heywang-Kobrunner SH, Kaiser WA, Kerin MJ, Mansel RE, Marotti L, Martincich L, Mauriac L, Meijers-Heijboer H, Orecchia R, Panizza P, Ponti A, Purushotham AD, Regitnig P, Del Turco MR, Thibault F, Wilson R. Magnetic resonance imaging of the breast: recommendations from the EUSOMA working group. Eur J Cancer. 2010 May;46(8):1296-316. doi: 10.1016/j.ejca.2010.02.015. Epub 2010 Mar 19.
- Background: PubMed 22476850Wu LM, Hu JN, Gu HY, Hua J, Chen J, Xu JR. Can diffusion-weighted MR imaging and contrast-enhanced MR imaging precisely evaluate and predict pathological response to neoadjuvant chemotherapy in patients with breast cancer? Breast Cancer Res Treat. 2012 Aug;135(1):17-28. doi: 10.1007/s10549-012-2033-5. Epub 2012 Apr 4.
- Background: PubMed 21286861Li XR, Cheng LQ, Liu M, Zhang YJ, Wang JD, Zhang AL, Song X, Li J, Zheng YQ, Liu L. DW-MRI ADC values can predict treatment response in patients with locally advanced breast cancer undergoing neoadjuvant chemotherapy. Med Oncol. 2012 Jun;29(2):425-31. doi: 10.1007/s12032-011-9842-y. Epub 2011 Feb 1.
- Background: PubMed 25268373Just N. Improving tumour heterogeneity MRI assessment with histograms. Br J Cancer. 2014 Dec 9;111(12):2205-13. doi: 10.1038/bjc.2014.512. Epub 2014 Sep 30.
- Derived from this study: PubMed 36635514Hottat NA, Badr DA, Lecomte S, Besse-Hammer T, Jani JC, Cannie MM. Assessment of diffusion-weighted MRI in predicting response to neoadjuvant chemotherapy in breast cancer patients. Sci Rep. 2023 Jan 12;13(1):614. doi: 10.1038/s41598-023-27787-x.
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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.
Mieke Cannie, MD principal investigator
CHU Brugmann
Nathalie Hottat, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI) in people with Breast Cancer, run by Brugmann University Hospital at 1 site in Belgium.
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 3 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 18 Jan 2020. 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 Belgium. 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?
Apparent diffusion coefficient (ADC) (mm2/sec) (time frame: Baseline: start of the neo-adjuvant therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02798484, which also lists 9 linked publications.
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 18 Jan 2020.