The representation of the breast on the somatosensory cortex after autologous breast reconstruction using 7 Tesla functional MRI

Completed

Conditions: Sensation of the breast
sensibility of the breast
10006291
10006295

Registration Number: NL-OMON56123

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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 initial surgery
- Informed consent

Exclusion Criteria

- Bilateral mastectomy / breast reconstruction
- Active disease / metastasis
- Previous radiation therapy on the breast 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)
--Pacemaker/ICD, implanted pumps or stimulators
-- Claustrophobia
-- Epilepsy
-- Heart rhythm disorders
-- Pregnancy
-- Permanent make-up or tattoos in head and neck area

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The hemodynamic response after stimulation of the skin of the breast and<br /><br>nipple-areola complex, representing neuronal activity in that region, is<br /><br>measured. Within the somatosensory cortex (S1 and S2), the temporo-spatial<br /><br>brain activity patterns after the various stimulation conditions are assessed,<br /><br>and the representation of the breast on the somatosensory cortex is mapped. </p><br>

Secondary Outcome Measures