Breast CancerNCT03750240
Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
A study testing Sodium (Na) Magnetic Resonance Imaging (MRI) and Dynamic Contrast- Enhanced (DCE) MRI in people with Breast Cancer and Triple Negative Breast Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive disease, and guide additional therapies for patients with inadequate response, if detected early. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- Sodium (Na) Magnetic Resonance Imaging (MRI) and Dynamic Contrast- Enhanced (DCE) MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2017to 24 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with no sign of breast cancer as controls
- Non-pregnant and non-lactating
- Ability to understand and willingness to sign a written consent
Who cannot join
- Contra-indications to MRI (i.e., ferromagnetic prostheses, metallic surgical implants that are not compatible with an MRI machine, claustrophobia etc.)
- Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
- Pregnant or lactating women, women using hormonal treatment in the 6 months prior to the study.
- Women with history of breast disease, previous breast surgery, or breast implants.
- Patients with a currently active second malignancy other than non-melanoma skin cancers. Patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for 3 years.
- Psychiatric illness or other conditions and circumstances which could prevent the patient from being compliant with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive disease, and guide additional therapies for patients with inadequate response, if detected early. Investigators propose to develop a sodium breast MRI technique that will allow to assess the early metabolic response of breast cancer to NACT, occurring before late structural changes can be detected with standard MRI.
This study will scan 12 patients using 1H/23Na MRI at 7 T and DCE MRI with triple-negative breast cancer undergoing AC-T therapy (2 months of Adriamycin + Cyclophosphamide, then 3 months of Taxol): at baseline (pre-NACT); after the first AC cycle (2 weeks); after AC treatment (2 months); after complete NACT (5 months, pre-surgery).
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Being tested
- Sodium (Na) Magnetic Resonance Imaging (MRI), Dynamic Contrast- Enhanced (DCE) MRI
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium (Na) Magnetic Resonance Imaging (MRI)Diagnostic test
Two Na data will be acquired:
- FLORET without Inversion Recovery (IR), and
- FLORET with IR
Dynamic Contrast- Enhanced (DCE) MRIDiagnostic test
DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data
| Study group | Role | What they receive |
|---|---|---|
| Triple Negative Breast Cancer Patients | Experimental | scanned 4 times to assess breast cancer response to NACT with the proposed method. Receives: Diagnostic Test: Sodium (Na) Magnetic Resonance Imaging (MRI); Diagnostic Test: Dynamic Contrast- Enhanced (DCE) MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tumor Size
Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.
Measured: Baseline, 2 Years
Secondary outcomes (2)
Total Sodium Concentration (TSC)
TSC was directly measured from 23Na images using a phantom calibration
Measured: Baseline
Intracellular Sodium Concentration (CIC)
CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start25 Jul 2017
- Primary completion24 Jun 2021
- Study completion24 Jun 2021
Why it stopped: technical difficulties for scans on the research MRI system
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Guillaume Madelin, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750240
- Sponsor's protocol ID
- 17-00269
- Status last verified
- Aug 2022
- First submitted
- 20 Nov 2018
- Last updated
- 24 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03750240
- Acronym / sponsor ID
- 17-00269
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: technical difficulties for scans on the research MRI system
- Enrolment
- 2 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Posted 24 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive disease, and guide additional therapies for patients with inadequate response, if detected early. Investigators propose to develop a sodium breast MRI technique that will allow to assess the early metabolic response of breast cancer to NACT, occurring before late structural changes can be detected with standard MRI.
This study will scan 12 patients using 1H/23Na MRI at 7 T and DCE MRI with triple-negative breast cancer undergoing AC-T therapy (2 months of Adriamycin + Cyclophosphamide, then 3 months of Taxol): at baseline (pre-NACT); after the first AC cycle (2 weeks); after AC treatment (2 months); after complete NACT (5 months, pre-surgery).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple Negative Breast Cancer Patients | Experimental | Diagnostic Test: Sodium (Na) Magnetic Resonance Imaging (MRI), Diagnostic Test: Dynamic Contrast- Enhanced (DCE) MRIscanned 4 times to assess breast cancer response to NACT with the proposed method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with no sign of breast cancer as controls
- Non-pregnant and non-lactating
- Ability to understand and willingness to sign a written consent
Key exclusion criteria (6 listed)
- Contra-indications to MRI (i.e., ferromagnetic prostheses, metallic surgical implants that are not compatible with an MRI machine, claustrophobia etc.)
- Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
- Pregnant or lactating women, women using hormonal treatment in the 6 months prior to the study.
- Women with history of breast disease, previous breast surgery, or breast implants.
- Patients with a currently active second malignancy other than non-melanoma skin cancers. Patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for 3 years.
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 |
|---|---|---|
| Sodium (Na) Magnetic Resonance Imaging (MRI)Two Na data will be acquired: 1. FLORET without Inversion Recovery (IR), and 2. FLORET with IR | Diagnostic test | Triple Negative Breast Cancer Patients |
| Dynamic Contrast- Enhanced (DCE) MRIDCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data | Diagnostic test | Triple Negative Breast Cancer Patients |
Primary outcome
Change in Tumor Size
Time frame: Baseline, 2 Years
Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.
2 secondary outcomes
Total Sodium Concentration (TSC)
Time frame: Baseline
Intracellular Sodium Concentration (CIC)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Guillaume Madelin, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium (Na) Magnetic Resonance Imaging (MRI) and Dynamic Contrast- Enhanced (DCE) MRI in people with Breast Cancer and Triple Negative Breast Cancer, run by NYU Langone Health at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 24 Aug 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 States. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Tumor Size (time frame: Baseline, 2 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 24 Aug 2022.