Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-29 @ 11:01 AM
Study NCT ID:
NCT01427166
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2011-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Invasive Imaging for Cording in Breast Cancer Patients
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Evaluation of Non Invasive Imaging for Assessing the Pathophysiology of Cording in Patients Treated for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Cords are bands of tissue that are present in the axilla following breast cancer surgery and may extend across the antecubital fossa and into the forearm. Cords are often painful to patients and limit their shoulder range of motion.The proposed study design involves the recruitment of patients who are enrolled in Partners Protocol # 2008P000540, a prospective analysis of symptoms, functionality and quality of life questionnaire to evaluate lymphedema in patients following treatment for breast cancer. This protocol recruits newly diagnosed breast cancer patients prior to any treatment interventions. Subjects are required to undergo volumetric arm measurements and complete the Lymphedema Evaluation Following Treatment for Breast Cancer Questionnaire (LEFT-BC) which will allow for the evaluation of changes in functionality, upper extremity utilization (fear associated avoidance), and quality of life. Throughout treatment patients will be screened before and after each treatment event: surgery, chemotherapy and radiation. Following the conclusion of treatment for breast cancer, patients will be measured at least 2 times per year (every 4-7 months). If during these study visits the patient notes cording symptoms, the research staff administering the questionnaire will be alerted. At this point, they will notify a designated medical provider who will perform a physical examination of the area to confirm the presence of cording. Once the presence of cording is verified, the patient will be provided with the opportunity to enroll in the proposed trial. Due to the current limited knowledge on the nature of the condition, the patients arm and axilla will have to be imaged within 7 days of the physical exam confirmation. The patients will be asked to return to the vascular imaging lab located on the Massachusetts's General Hospital's main campus. They will undergo a venous duplex ultrasound, on a General Electric LOGIQ-9 unit with a Phillips-IU-22 probe.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA139118 | NIH | None | https://reporter.nih.gov/quic… | View |