Lymphatic Function in Patients Who Have Undergone Breast Cancer Treatment

Summary

Protocol resume

Swelling of tissue due to excess fluid, called lymphedema, is a common side effect of breast cancer treatment that requires lifelong treatment but in what way the treatment of breast cancer affects the lymphatic vasculature is not yet fully understood.

The overall aim of this study is to examine the baseline lymphatic function and anatomy in women who have undergone and completed treatment for breast cancer.

Comparison will be made between:

* The treated arm and the untreated arm in the participant.
* The treated arm in patients who did not develop lymphedema and the treated arm in patients who did.

By using an emerging technique, Near Infrared fluorescence imaging (NIRF), and non-contrast MRI it is now possible to examine the link between breast cancer treatment and the development of lymphedema. This project will describe the impact of breast cancer treatment on contractile function and morphological changes of the lymphatic vasculature in the upper extremity in patients treated for breast cancer.

The study population will consist of 28 patients treated for breast cancer who simultaneously are enrolled in the Skagen 1 trial. The NIRF imaging and MRI will be performed after completion of breast cancer treatment and no later than half a year after completion treatment. All examinations will be made under similar conditions, on the same segment of lymphatic vasculature, in the same room and bed and with patients in the supine position. The estimated duration of each examination is approximately 3,5 hours.

Upon arrival participants will receive three injections of ICG distally on each arm, two on the dorsal side and one on the palmar side. Ten minutes after injection, the primary sequence of the lymphatic vessels will be recorded, allowing for calculation of frequency and velocity. Following, the pumping pressure of the lymphatic vessels will be estimated. After completion of the NIRF examination, an MRI scan of the upper body and extremities will be made, allowing for morphological evaluation of the lymphatic system in the region.

By studying the lymphatic vessels in these patients, data may elucidate the characteristics of the changes taking place and thus provide new insight for future studies and possibly future treatments and ways to prevent or reduce the development of edema.

Conditions

• Secondary Lymphedema

Interventions

DRUG

Indocyanine Green (ICG)

Injection of ICG as a fluorophore for Near Infrared fluorescence Imaging (NIRF)

Sponsors & Collaborators

• Novo Nordisk A/S

  collaborator INDUSTRY

• University of Aarhus

  lead OTHER

Principal Investigators

• Vibeke Hjortdal, professor · Department of Cardiothoracic and Vascular Surgery

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-30

Primary Completion

2019-02-28

Completion

2019-08-31

Countries

• Denmark

Study Locations