Breast CancerNCT03374826
PET-MRI for Axillary Staging in Node Negative Breast Cancer Patients
A study testing Dedicated axillary hybrid PET-MRI in people with Breast Cancer and Breast Neoplasms, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
Axillary lymph node status is an important prognostic factor for patients with breast cancer. After breast cancer diagnosis, current nodal staging consists of axillary ultrasound (US) combined with tissue sampling when deemed necessary. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Diseases
- What is being tested?
- Dedicated axillary hybrid PET-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesNetherlands
- Study dates
- 22 Feb 2018to Dec 2023
- 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
- Female patient with histologically confirmed breast cancer and clinically confirmed negative lymph nodes in the axilla, scheduled to undergo SLNB
- Patients who are willing and able to undergo the study procedures
- The patient has provided personally written informed consent
Who cannot join
- Patients treated with neoadjuvant systemic therapy prior to axillary nodal staging
- Patients with clinically positive axillary lymph nodes
- Age < 18 years
- Inability to provide informed consent
- Pregnancy
- Weight >100 kg (because of the format of the PET/MRI scanner)
- General contraindications for MRI (such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia) or PET (i.e. known allergy to 18F-FDG)
- Hyperglycaemia (> 11 mmol/L) at the time of 18F-FDG injection
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht
Kees de Mooij, MD, +31 43 388 5054, c.demooij@maastrichtuniversity.nl
Marjolein Smidt, MD, PhD
- Recruiting
Erasmus Medical Center
Rotterdam, 3015GD
Cécile de Monyé, MD, PhD, 0031-7040265, c.demonye@erasmusmc.nl
Cécile de Monyé, MD, PhD
About this study
Official title: Non-invasive Axillary Lymph Node Staging in Breast Cancer With PET-MRI
Axillary lymph node status is an important prognostic factor for patients with breast cancer. After breast cancer diagnosis, current nodal staging consists of axillary ultrasound (US) combined with tissue sampling when deemed necessary. In case of positive axillary lymph nodes, patients will undergo axillary lymph node dissection (ALND). In case of no suspicious axillary lymph nodes (i.e. clinically node negative patients), patients will undergo sentinel lymph node biopsy (SLNB). This surgical nodal staging is accompanied by co-morbidity. In theory, if non-invasive imaging can evaluate the lymph node status accurately, a node negative patient would no longer have to undergo axillary surgery. Since MRI is suitable for soft tissue imaging and PET has the advantage of showing increased metabolic uptake in lymph node metastases, a combination of these techniques in hybrid PET/MRI would be highly desirable. If dedicated axillary hybrid PET/MRI is equally accurate to SLNB for the detection of negative axillary lymph nodes, work-up could be more efficient by bypassing SLNB. However, the accuracy of dedicated axillary hybrid PET/MRI needs to be compared with the pathological outcome of SLNB (gold standard) first.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Diseases
- Being tested
- Dedicated axillary hybrid PET-MRI
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dedicated axillary hybrid PET-MRIDiagnostic test
All clinically node negative patients will undergo a hybrid PET-MRI axilla preoperatively, followed by breast surgery and SLNB.
| Study group | Role | What they receive |
|---|---|---|
| Dedicated axillary hybrid PET-MRI axilla | Experimental | Not described Receives: Diagnostic Test: Dedicated axillary hybrid PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of dedicated hybrid PET/MRI
Accuracy (sensitivity, negative predictive value (NPV) and false negative rate (FNR)) of dedicated axillary hybrid PET/MRI to exclude axillary lymph node metastases will be calculated.
Measured: Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks
Secondary outcomes (1)
Accuracy of T2w MRI, DWI and Hybrid PET/MRI
Accuracy (sensitivity, negative predictive value (NPV) and false negative rate (FNR)) of three MRI sequences (T2w, DWI and hybrid PET/MRI) to exclude axillary lymph node metastases will be calculated separately as well.
Measured: Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start22 Feb 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (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.
- More trials run by Maastricht University Medical CenterThe 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374826
- Sponsor's protocol ID
- NL62441.068.17
- Status last verified
- Oct 2023
- First submitted
- 28 Nov 2017
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Axillary Lymph Node Staging in Breast Cancer With PET-MRI
- ClinicalTrials.gov ID
- NCT03374826
- Acronym / sponsor ID
- NL62441.068.17
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Dec 2017 (actual)
- 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.
Axillary lymph node status is an important prognostic factor for patients with breast cancer. After breast cancer diagnosis, current nodal staging consists of axillary ultrasound (US) combined with tissue sampling when deemed necessary. In case of positive axillary lymph nodes, patients will undergo axillary lymph node dissection (ALND). In case of no suspicious axillary lymph nodes (i.e. clinically node negative patients), patients will undergo sentinel lymph node biopsy (SLNB). This surgical nodal staging is accompanied by co-morbidity. In theory, if non-invasive imaging can evaluate the lymph node status accurately, a node negative patient would no longer have to undergo axillary surgery. Since MRI is suitable for soft tissue imaging and PET has the advantage of showing increased metabolic uptake in lymph node metastases, a combination of these techniques in hybrid PET/MRI would be highly desirable. If dedicated axillary hybrid PET/MRI is equally accurate to SLNB for the detection of negative axillary lymph nodes, work-up could be more efficient by bypassing SLNB. However, the accuracy of dedicated axillary hybrid PET/MRI needs to be compared with the pathological outcome of SLNB (gold standard) first.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dedicated axillary hybrid PET-MRI axilla | Experimental | Diagnostic Test: Dedicated axillary hybrid PET-MRI |
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)
- Female patient with histologically confirmed breast cancer and clinically confirmed negative lymph nodes in the axilla, scheduled to undergo SLNB
- Patients who are willing and able to undergo the study procedures
- The patient has provided personally written informed consent
Key exclusion criteria (8 listed)
- Patients treated with neoadjuvant systemic therapy prior to axillary nodal staging
- Patients with clinically positive axillary lymph nodes
- Age < 18 years
- Inability to provide informed consent
- Pregnancy
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 |
|---|---|---|
| Dedicated axillary hybrid PET-MRIAll clinically node negative patients will undergo a hybrid PET-MRI axilla preoperatively, followed by breast surgery and SLNB. | Diagnostic test | Dedicated axillary hybrid PET-MRI axilla |
Primary outcome
Accuracy of dedicated hybrid PET/MRI
Time frame: Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks
Accuracy (sensitivity, negative predictive value (NPV) and false negative rate (FNR)) of dedicated axillary hybrid PET/MRI to exclude axillary lymph node metastases will be calculated.
1 secondary outcome
Accuracy of T2w MRI, DWI and Hybrid PET/MRI
Time frame: Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Maastricht University Medical Center
Maastricht, Netherlands
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dedicated axillary hybrid PET-MRI in people with Breast Cancer and Breast Neoplasms, run by Maastricht University Medical Center at 2 sites in Netherlands.
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 8 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 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of dedicated hybrid PET/MRI (time frame: Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks). 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 31 Oct 2023.