Lymphatic Function in Patients Who Have Undergone Breast Cancer Treatment

NCT03572998 | Unknown DMC

• 2 other identifiers: 2204931-10-72-193-18
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Pumping pressure

  The pumping pressure in the lymphatic vessels.

  during the 3.5 hours study

• Velocity

  The velocity of the lymphatic fluid

  during the 3.5 hours study

• Frequency

  the frequency of contraction of the lymphatic vessels

  during the 3.5 hours study

• morphology

  The morphology of the lymphatic vessels

  During the 60 minutes MRI scan

Study Arms (1)

Breast cancer patients

OTHER

study subject

Drug: Indocyanine Green (ICG)

Interventions

Indocyanine Green (ICG) DRUG

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

Breast cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Aarhus University

Aarhus C, Danmark, 8000, Denmark

RECRUITING

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vibeke Hjortdal, professor

  Department of Cardiothoracic and Vascular Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathias Alstrup, stud.med

CONTACT

61330876; malstrup@clin.au.dk

Shayant Mohanakumar, cand.med.

CONTACT

shey@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case-control. Patients function as their own control since the treated arm will be compared with the non-treated arm.

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: September 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

DK (1)