Functional MRI Study Reconstructed Breasts

The Representation of the Breast on the Somatosensory Cortex After Autologous Breast Reconstruction Using 7 Tesla Functional MRI.

Rationale: To study the effects of mastectomy and autologous breast reconstruction on the sensation of the (reconstructed) breast, not only the peripheral reinnervation of the breast should be studied, but also the changes that take place in the somatosensory cortex. Now that the region of interest in the brain and the somatotopy of the non-operated breast are known, studies with patients who underwent mastectomy and breast reconstruction are the next step to understand the neuroplasticity of the brain following breast surgery.

Objective: To study the neuroplasticity of the brain after mastectomy and breast reconstructive surgery by assessing the somatotopy of the breast on the somatosensory cortex of patients who underwent either breast reconstruction with and without nerve restoration or mastectomy without breast reconstruction.

Study design: A single center imaging study carried out in Maastricht University Medical Center.

Study population: A total of 30 female breast cancer patients who underwent a unilateral mastectomy without breast reconstruction or a mastectomy followed by a unilateral autologous breast reconstruction with a deep inferior epigastric artery perforator (DIEP) flap will be included in this study. Three groups of patients will be selected and compared: ten patients who underwent a mastectomy without breast reconstruction, ten patients who underwent a DIEP flap breast reconstruction with sensory nerve restoration of the flap and ten patients who underwent a DIEP flap without nerve restoration.

Intervention: Every subject will undergo a single functional MRI scan in a 7 Tesla MRI scan at least six months after the operation. A scanning session takes approximately 75 minutes. During the scan, piezo-electric stimulators are applied to both the reconstructed and non-operated breast in a fixed pattern. These stimulators stimulate the skin and sensory nerves of the breast and nipple-areola complex in a random sequence.

Main study parameters: The hemodynamic response after stimulation of the skin of the breast and nipple-areola complex, representing neuronal activity in that region, is measured. Within the somatosensory cortex (S1 and S2), the temporo-spatial brain activity patterns after the various stimulation conditions are assessed, and the representation of the breast on the somatosensory cortex is mapped.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: MRI scan

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female over 18 years old
• Unilateral mastectomy without breast reconstruction
• Unilateral mastectomy with DIEP flap breast reconstruction (with or without sensory nerve restoration)
• At least six months after the operation
• Informed consent

Exclusion Criteria:

• Bilateral mastectomy / breast reconstruction
• Previous surgery, disease or treatment of the contralateral breast
• Active disease / metastasis
• Previous radiation therapy on the chest or axilla
• Diseases associated with neuropathy (e.g. diabetes mellitus)
• Previous brain surgery
• Previous allergic reactions to adhesives or plasters

• Any MRI exclusion criteria:

  • No piercings or other iron materials (except a metal brace behind front teeth)
  • Claustrophobia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mastectomy without breast reconstruction; Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.	Device: MRI scan; 7.0 tesla functional MRI scan
Active Comparator: Breast reconstruction with nerve; Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.	Device: MRI scan; 7.0 tesla functional MRI scan
Active Comparator: Breast reconstruction without nerve; Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.	Device: MRI scan; 7.0 tesla functional MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The neuroplasticity of the brain after breast reconstruction	Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex will be measured. Changes will be analysed using multi-voxel pattern analysis to localize the different parts of the breast in the somatosensory cortex.	75 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in the somatotopy between patients who underwent a breast reconstruction with nerve restoration compared to patients who underwent breast reconstruction without nerve restoration.	Differences between groups in somatotopy of the breast in the somatosensory cortex will be assessed.	75 minutes
Differences in the somatotopy between patients who underwent mastectomy without breast reconstruction compared to patients who underwent breast reconstruction.	Differences between groups in somatotopy of the breast in the somatosensory cortex will be assessed.	75 minutes

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: René van der Hulst, MD, PhD, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NL67696.068.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No