The main goal of this study is to study the accuracy (sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and false negative rate (FNR)) of dedicated axillary hybrid PET/MRI for the detection of negative…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The accuracy (sensitivity, specificity, PPV, NPV, FNR) of dedicated axillary
hybrid PET/MRI versus pathological outcome of SLNB will be investigated. The
accuracy of PET/MRI will be determined on the basis of node-by-node matching of
the imaged nodes to the pathological outcome of SLNB and patient-by-patient
analysis.
Secondary outcome
To investigate the diagnostic value of the three MRI sequences (T2w, DWI and
hybrid PET/MRI) using a dedicated axillary unenhanced hybrid PET/MRI protocol.
Background 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.
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 uptale 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 objective
The main goal of this study is to study the accuracy (sensitivity, specificity,
positive predictive value (PPV), negative predictive value (NPV), and false
negative rate (FNR)) of dedicated axillary hybrid PET/MRI for the detection of
negative axillary lymph nodes in breast cancer patients. The accuracy of
PET/MRI will be compared with the pathological outcome of SLNB.
Study design
The study is designed as a multi center prospective cohort study.
Intervention
If a patient provides informed consent, she will undergo a PET/MRI with
dedicated axillary coil before surgical staging. As contrast agent the
radioactive tracer 18F-FDG will be used (no gadolinium-based MRI contrast
agents). We will integrate this study in the regular treatment of the patient,
causing no delay in their treatment plan.
Study burden and risks
The patient who participates in this study will undergo regular investigations
of nodal staging in breast cancer. For this study we will perform an extra
PET/MRI of the axilla before the surgical staging. Furthermore, the
lymphoscintigraphy will be supplemented with a SPECT/CT scan for the
node-by-node matching. All further procedures are already included in the
regular treatment. Patients participating in this study do not directly benefit
themselves, but can help prevent future patients with negative axillary lymph
nodes from undergoing axillary surgery.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
1. Female patient with histologically confirmed breast cancer and clinically
confirmed negative lymph nodes in the axilla, scheduled to undergo SLNB
2. Patients who are willing and able to undergo the study procedures
3. The patient has provided personally written informed consent
Exclusion criteria
1. Patients treated with neoadjuvant systemic therapy prior to axillary nodal
staging
2. Patients with clinically positive axillary lymph nodes
3. Age < 18 years
4. Inability to provide informed consent
5. Pregnancy
6. Weight >100 kg (because of the format of the PET/MRI scanner)
7. 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)
8. Hyperglycaemia (> 11 mmol/L) at the time of 18F-FDG injection
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62441.068.17 |