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PET-MRI for Axillary Staging in Node Negative Breast Cancer Patients

Primary Purpose

Breast Cancer, Breast Neoplasms, Breast Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Dedicated axillary hybrid PET-MRI
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical CenterRecruiting
  • Erasmus Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dedicated axillary hybrid PET-MRI axilla

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 28, 2017
Last Updated
June 23, 2022
Sponsor
Maastricht University Medical Center
Collaborators
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03374826
Brief Title
PET-MRI for Axillary Staging in Node Negative Breast Cancer Patients
Official Title
Non-invasive Axillary Lymph Node Staging in Breast Cancer With PET-MRI
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Erasmus Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms, Breast Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dedicated axillary hybrid PET-MRI axilla
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Dedicated axillary hybrid PET-MRI
Intervention Description
All clinically node negative patients will undergo a hybrid PET-MRI axilla preoperatively, followed by breast surgery and SLNB.
Primary Outcome Measure Information:
Title
Accuracy of dedicated hybrid PET/MRI
Description
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.
Time Frame
Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks
Secondary Outcome Measure Information:
Title
Accuracy of T2w MRI, DWI and Hybrid PET/MRI
Description
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.
Time Frame
Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kees de Mooij, MD
Phone
+31 43 388 5054
Email
c.demooij@maastrichtuniversity.nl
First Name & Middle Initial & Last Name & Degree
Marjolein Smidt, MD, PhD
First Name & Middle Initial & Last Name & Degree
Thiemo van Nijnatten, MD, PhD
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile de Monyé, MD, PhD
Phone
0031-7040265
Email
c.demonye@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Cécile de Monyé, MD, PhD
First Name & Middle Initial & Last Name & Degree
Linetta Koppert, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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PET-MRI for Axillary Staging in Node Negative Breast Cancer Patients

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