Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

* Total mastectomy + immediate reconstructive surgery
* 6 months after surgery : Functional MRI and questionnaires

* Within 2 months before surgery : Functional MRI
* Reconstructive surgery
* 6 months after surgery : Functional MRI and questionnaires

Functional MRI

Claudia REGIS, MD

Breast reconstruction is an integral part of the management of patients with breast cancer and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying aesthetic and functional result (sensitivity) and that would enable the patient to appropriate the reconstructed breast. Patient satisfaction assessed subjectively by questionnaires would be better in autologous reconstructions than in reconstructions by prosthesis.

The aim of our trial is to use functional MRI (fMRI) as an objective evaluation tool to describe the brain functional changes of sensory projections after immediate or secondary breast reconstruction.

Patients responding criteria for selection and not objecting to participate in this trial will address a quality of life questionnaire at baseline. Then the study procedures differ depending on which group the patient belongs to.

Immediate breast reconstruction group : Six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fMRI will be performed and patients will be asked to complete a quality of life form and a satisfaction form.

Secondary breast reconstruction group :

* In the two months preceding the surgery, a preoperative fMRI will be performed.
* Six months after surgery (or six months after the implantation of the definitive prosthesis in case of use of a tissue expander), a postoperative fMRI will be performed and patients will be asked to complete a quality of life form and a satisfaction form.

Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)

University Hospital, Lille

Centre Oscar Lambret

Breast Diseases

Skin Diseases

All sorts of breast reconstructive surgery are allowed in this study in terms of timing, autologous/prosthetic and so forth.

Breast reconstructive surgery

Yong Bae Kim, MD, PhD

YongBae Kim, MD

This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.

Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy

Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy: Prospective Cohort Study

Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)

Yonsei University

FLARE imaging system

John V Frangioni, MD, PhD

The main purpose of this study is to test the ergonomics of an investigational imaging system that can take pictures of blood vessels under the skin. In plastic and reconstructive surgery, blood flow to tissue determines whether the tissue can be transplanted from one location to another. This new imaging device uses invisible near-infrared fluorescent light to see blood vessels that otherwise could not be seen by eye. This study will test the system's basic operation and ergonomics in the operating room.

To perform a pilot study of the FLARE™ NIR fluorescence imaging system in conjunction with indocyanine green (ICG) during breast reconstructive surgery utilizing deep inferior epigastric perforator (DIEP) flaps.

Due to patient-to-patient anatomic variation, the vascular perfusion to the cutaneous elements in flaps is unpredictable and of great concern to the surgeon planning the design of the flap. We propose a method of imaging the flap based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon.

Specific Aims:

A pilot optimization study of the imaging system in combination with ICG to determine optimal dose, light excitation fluence rate, and camera exposure time.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)	NCT02553967	Breast Cancer	Functional MRI	18 Years -	Centre Oscar Lambret
Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy	NCT03523078	Breast Cancer F...	Breast reconstr...	20 Years -	Yonsei University
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)	NCT02553967	Breast Cancer	Functional MRI	18 Years -	Centre Oscar Lambret
Objective Flap Assessment During Reconstructive Surgery	NCT00952107	Cancer	FLARE imaging s...	21 Years -	Beth Israel Deaconess Medical Center

Spots Global Cancer Trial Database for breast reconstructive surgery