Mapping lymphatic drainage pathways in women with breast cancer
Variable Anatomy and Function of the Arm's Alternate Lymphatic Pathway
This study is trying to see if differences in lymphatic pathways in healthy women and breast cancer survivors can help predict who might develop lymphedema after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05253352 on ClinicalTrials.gov |
What this trial studies
This study evaluates the anatomy of the lymphatic system pathways in healthy women and breast cancer survivors who did not develop lymphedema after treatment. Using advanced imaging techniques like indocyanine green lymphography and SPECT/CT, the researchers aim to identify variations in the Mascagni-Sappey pathway that may influence the risk of developing lymphedema. The goal is to better understand these anatomical differences and potentially predict which women are at higher risk for lymphedema. This observational study will involve participants who meet specific eligibility criteria related to their breast cancer treatment history.
Who should consider this trial
Good fit: Ideal candidates are women who have undergone breast cancer treatment with axillary lymph node dissection and are at least 18 years old.
Not a fit: Patients with a history of lymphedema, bilateral lymph node surgery, or other specified exclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for women at risk of developing lymphedema after breast cancer treatment.
How similar studies have performed: While this approach is innovative, similar studies have not been extensively documented, indicating that this may be a novel investigation into lymphatic anatomy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * History of breast cancer treatment including ALND - defined by removal of \>=10 lymph nodes - more than 2 years before study participation * Ability to understand the protocol and willingness to participate * At least 18 years of age Exclusion Criteria: * Prior history of bilateral lymph node surgery * Prior history of other surgical procedures of the affected upper extremity besides the axillary management for breast cancer treatment * Prior history of chronic inflammatory conditions (e.g. rheumatoid arthritis) * Prior history of filarial infections * Prior history of lymphedema * Patient-reported pregnancy * Patients who are breastfeeding * Iodine allergy * Prior history of upper extremity deep vein thrombosis * Prior history of congestive heart failure * Prior history of venous thoracic outlet syndrome * Current active cancer
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Dhruv Singhal, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Angela Chen, BS
- Email: achen22@bidmc.harvard.edu
- Phone: 6176327043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.