Lymphatic Function in Patients Who Have Undergone Breast Cancer Treatment

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborator: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Women who are being enrolled in the Skagen 1 Trial. The inclusion criteria for the Skagen 1 Trial and therefore this study is as follows:

• Woman ≥ 18 years who had radical operation for invasive breast cancer pT1-3, pN0-N3, M0 with either mastectomy or breast conservation. The patient can be included no matter the status of estrogen receptor, progesterone receptor, malignancy grade, HER2 status.

• Axillary lymph node dissection of the axilla where the findings give indication for regional nodes radiation therapy to levels (I), II, III, IV, interpectoral nodes and the IMN.

• Sentinel node biopsy documenting limited nodal disease without an indication for axillary lymph node dissection according to institutional, national or other trial guidelines.

• The patient may be a candidate for boost to the tumour bed.

• Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.

• Neoadjuvant chemotherapy to downstage a cT3-cT4 or cN2-cN3 breast cancer is accepted if there is not an indication for a boost in the area of regional nodes after surgery.

• Primary systemic therapy of an operable breast cancer is accepted.

• If the patient is not treated with chemotherapy she must be randomised within 42 days from last surgery. If she has received chemotherapy she must be randomised within 4 weeks after the last series of chemotherapy.

• Breast implants are accepted.

• Connective tissue disease is allowed if the treating clinical/radiation oncologist finds radiation therapy indicated.

• Postoperative infection and/or seroma giving indication for drainage during RT is accepted

• Patient with previous non-breast malignancy is accepted if the patient has been without disease minimum 5 years, and the treating oncologist estimates a low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ cervicis, carcinoma in situ coli, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin.

• Life expectancy minimum 10 years.

Exclusion Criteria:

• Previous breast cancer or DCIS of the breast.

• Bilateral breast cancer.

• The patient has an indication for boost to 1 or more regional nodes.

• Previous radiation therapy to the chest region.

• Pregnant or lactating.

• Conditions indicating that the patient cannot go through the radiation therapy or follow up, or a condition where the treating oncologist thinks the patient should not participate in the trial for example due to language problems.

• Known iodide allergy.

• Claustrophobia.

• Foreign objects of metal.