Non-Invasive Imaging for Cording in Breast Cancer Patients

NCT01427166 | Completed DMC

• 2 other identifiers: 10-279R01CA139118
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

To date, the scientific literature has yet to provide sufficient evidence regarding the pathophysiology of cording. The objective of this protocol is to evaluate the utility of non invasive vascular imaging for assessing the pathophysiology of cording in a small study cohort of patients who were treated for breast cancer. The hypothesis is that cording may have a vascular etiology

Conditions

Breast Cancer

Keywords

Breast Cancer; Cording; Lymphedema; upper extremity cording; following treatment

Outcome Measures

Primary Outcomes (1)

• The pathophysiology of cording following treatment for breast cancer

  The cohort of 15 subject's images will be reviewed by the PI and a designated physician from the department of vascular medicine to determine if there is a vascular origin in the cords. Each image will be accessed for the following findings or involvement: Venous, lymphatic, fluid pockets, and striations on the cord.

  7 days

Secondary Outcomes (1)

• Cording and the onset of breast cancer related lymphedema

  30 days

Study Arms (1)

Ultrasound imaging

EXPERIMENTAL

Cords that are present in the participant's axilla and/or arm will be imaged with an ultrasound

Other: Non invasive venous ultrasound

Interventions

Non invasive venous ultrasound OTHER

Subjects will undergo a venous duplex ultrasound, on a General Electric LOGIQ-9 unit with a Phillips-IU-22 probe

Ultrasound imaging

Eligibility Criteria

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

You may qualify if:

• Participants must be enrolled in Partners protocol # 2008P000540 "Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer"
• Confirmed case of cording by a medical provider (Physician, Nurse Practitioner, Physician Assistant)
• Participants must be at least 18 years of age
• Life expectancy of greater than 1 year.
• Ability to understand and the willingness to sign a written informed consent document.
• Willingness to comply with required follow up Perometer measurements and clinical visits.

You may not qualify if:

• Participants who are not enrolled or have been removed from Partners Protocol # 2008P000540 will be excluded from this trial.
• Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• History of prior surgery or radiation to the head, neck, upper limb, or trunk.
• Patients with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Alphonse G Taghian, MD PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Breast Service

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: September 1, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

US (1)