Mapping and Quantifying Lymphatic Drainage of the Arm's Alternate Pathway
Using indocyanine green (ICG) lymphography and lymphoscintigraphy with SPECT/CT imaging, the aim is to evaluate the anatomy of the lymphatic system pathway in two separate populations: healthy female volunteers and women with a history of breast cancer who did not develop lymphedema.
| Condition(s) | Lymphatic System |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Using indocyanine green (ICG) lymphography and lymphoscintigraphy with SPECT/CT imaging, the aim is to evaluate the anatomy of the lymphatic system pathway in two separate populations: healthy female volunteers and women with a history of breast cancer who did not develop lymphedema. |
| Who can participate | 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 * P |
| Ages | 18 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Beth Israel Deaconess Medical Center |
| Locations | Boston, Massachusetts, United States |
| Start date | 2022-04-01 |
| NCT ID | NCT05253352 |
| Official listing | https://clinicaltrials.gov/study/NCT05253352 |