Lymphatic SystemNCT05253352
Mapping and Quantifying Lymphatic Drainage of the Arm's Alternate Pathway
An observational study of Lymphatic System, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphatic System
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with a history of breast cancer treatment including axillary lymph node dissection (ALND) more than 2 years prior to study participation, who did not develop lymphedema.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dhruv Singhal, MD, 617-632-7855
About this study
Official title: Variable Anatomy and Function of the Arm's Alternate Lymphatic 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.
Read the detailed description
Breast Cancer Related Lymphedema (BCRL) affects 1.2 million patients in the United States and has no cure. The symptoms of lymphedema include fatigue, tightness, pain, and life-threatening infections. However, two-thirds of women undergoing breast cancer treatment with the highest risk factors for developing lymphedema do not develop the disease. While there is no explanation for this finding, one hypothesis is that normal anatomic variations of the lymphatic system pre-dispose certain women to developing lymphedema after breast cancer treatment. Specifically, the main back-up lymphatic pathway of the arm, the Mascagni-Sappey (M-S) pathway, is variably present in cadaver studies and avoids areas that are usually damaged with breast cancer treatment. Moreover, when present in these cadaver studies, the M-S pathway has variable anatomic connections which can impact its ability to drain the arm effectively. The investigators hypothesize that, utilizing modern imaging techniques, the investigators can define the anatomy of the M-S pathway and its variations in normal women and in breast cancer survivors who have undergone high risk breast cancer treatment and did not develop lymphedema. Utilizing this information, the investigators will be able to predict which variations predispose women to develop lymphedema. Finally, the investigators will develop a novel method of non-invasive intraoperative optical imaging to assess the function of this pathway during breast cancer operations to predict the patient's risk of developing lymphedema. The ability to evaluate real-time lymphatic function would allow cancer teams to implement preventive interventions in high risk patients. As the most common cause of lymphedema in the United States is secondary to cancer procedures, this model of lymphedema prevention could be widely applied to the treatment of other high risk cancer populations including gynecologic cancers, urologic cancers, skin cancers, and sarcomas.
The investigators will use ICG lymphography and lymphoscintigraphy with SPECT/CT (single-photon emission computed tomography) imaging to evaluate the anatomy of the M-S pathway in two separate populations:
Group 1: The research study staff will recruit healthy female volunteers without a history of lymphedema or ALND (axillary lymph node dissection) surgery to map the normal anatomy of the M-S pathway. The investigators hope to quantify the percentage of women who do not have this pathway present, do not have peripheral connections between the M-S pathway and the forearm, and/or whose terminal M-S pathway draining nodal basins are in the axilla.
Group 2: Research study staff will measure changes that occur in the M-S pathway anatomy in women at least 2 years status-post ALND surgery without developing lymphedema in the time following their surgery (Aim 2) using the same methodology. By understanding the M-S pathway anatomy in relation to the main lymphatic drainage pathway of the forearm in the setting of an ALND without lymphedema the investigators can gain critical insight about which patients are at the highest risk of developing BCRL and why this is more likely to occur in some patients than others.
- Conditions
- Lymphatic System
- Keywords
- anatomy, lymphatic system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy female volunteers with no history of lymphedema. Physical therapy examination, ICG lymphography, venous ultrasound and lymphoscintigraphy with SPECT/CT imaging | |
| Women with breast cancer who did not develop lymphedema | Women who have had an axillary lymph node dissection (ALND) and did not develop lymphedema. Physical therapy examination, ICG lymphography, venous ultrasound and lymphoscintigraphy with SPECT/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphatic pathway anatomy of the upper extremity
Indocyanine green (ICG) lymphography of bilateral upper arms
Measured: Study Visit 1: Immediately after ICG lymphography injections
Lymphatic pathway anatomy of the upper extremity
Lymphoscintigraphy scans of bilateral upper arms
Measured: Study Visit 1: 30 min after lymphoscintigraphy tracer injection
Lymphatic pathway anatomy of the upper extremity
Lymphoscintigraphy scans of bilateral upper arms
Measured: Study Visit 1: 2 hours after lymphoscintigraphy tracer injection
Lymphatic pathway anatomy of the upper extremity (SPECT/CT)
SPECT/CT lymphoscintigraphy scans of bilateral upper arms
Measured: Study Visit 1: 2 hours after lymphoscintigraphy tracer injection
Lymphatic pathway anatomy of the upper extremity
Lymphoscintigraphy scans of bilateral upper arms
Measured: Study Visit 2: 30 min after lymphoscintigraphy tracer injection
Lymphatic pathway anatomy of the upper extremity
Lymphoscintigraphy scans of bilateral upper arms
Measured: Study Visit 2: 2 hours after lymphoscintigraphy tracer injection
Lymphatic pathway anatomy of the upper extremity (SPECT/CT)
SPECT/CT lymphoscintigraphy scans of bilateral upper arms
Measured: Study Visit 2: 2 hours after lymphoscintigraphy tracer injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Apr 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic SystemStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Dhruv Singhal, Beth Israel Deaconess Medical Center
- Investigators
- Dhruv Singhal, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253352
- Sponsor's protocol ID
- 2021P000209
- Other IDs
- 1R01HL157991-01
- Status last verified
- Mar 2026
- First submitted
- 11 Feb 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variable Anatomy and Function of the Arm's Alternate Lymphatic Pathway
- ClinicalTrials.gov ID
- NCT05253352
- Acronym / sponsor ID
- 2021P000209
- Conditions
- Lymphatic System
- Keywords
- anatomy, lymphatic system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast Cancer Related Lymphedema (BCRL) affects 1.2 million patients in the United States and has no cure. The symptoms of lymphedema include fatigue, tightness, pain, and life-threatening infections. However, two-thirds of women undergoing breast cancer treatment with the highest risk factors for developing lymphedema do not develop the disease. While there is no explanation for this finding, one hypothesis is that normal anatomic variations of the lymphatic system pre-dispose certain women to developing lymphedema after breast cancer treatment. Specifically, the main back-up lymphatic pathway of the arm, the Mascagni-Sappey (M-S) pathway, is variably present in cadaver studies and avoids areas that are usually damaged with breast cancer treatment. Moreover, when present in these cadaver studies, the M-S pathway has variable anatomic connections which can impact its ability to drain the arm effectively. The investigators hypothesize that, utilizing modern imaging techniques, the investigators can define the anatomy of the M-S pathway and its variations in normal women and in breast cancer survivors who have undergone high risk breast cancer treatment and did not develop lymphedema. Utilizing this information, the investigators will be able to predict which variations predispose women to develop lymphedema. Finally, the investigators will develop a novel method of non-invasive intraoperative optical imaging to assess the function of this pathway during breast cancer operations to predict the patient's risk of developing lymphedema. The ability to evaluate real-time lymphatic function would allow cancer teams to implement preventive interventions in high risk patients. As the most common cause of lymphedema in the United States is secondary to cancer procedures, this model of lymphedema prevention could be widely applied to the treatment of other high risk cancer populations including gynecologic cancers, urologic cancers, skin cancers, and sarcomas.
The investigators will use ICG lymphography and lymphoscintigraphy with SPECT/CT (single-photon emission computed tomography) imaging to evaluate the anatomy of the M-S pathway in two separate populations:
Group 1: The research study staff will recruit healthy female volunteers without a history of lymphedema or ALND (axillary lymph node dissection) surgery to map the normal anatomy of the M-S pathway. The investigators hope to quantify the percentage of women who do not have this pathway present, do not have peripheral connections between the M-S pathway and the forearm, and/or whose terminal M-S pathway draining nodal basins are in the axilla.
Group 2: Research study staff will measure changes that occur in the M-S pathway anatomy in women at least 2 years status-post ALND surgery without developing lymphedema in the time following their surgery (Aim 2) using the same methodology. By understanding the M-S pathway anatomy in relation to the main lymphatic drainage pathway of the forearm in the setting of an ALND without lymphedema the investigators can gain critical insight about which patients are at the highest risk of developing BCRL and why this is more likely to occur in some patients than others.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –Healthy female volunteers with no history of lymphedema. Physical therapy examination, ICG lymphography, venous ultrasound and lymphoscintigraphy with SPECT/CT imaging |
| Women with breast cancer who did not develop lymphedema | – | –Women who have had an axillary lymph node dissection (ALND) and did not develop lymphedema. Physical therapy examination, ICG lymphography, venous ultrasound and lymphoscintigraphy with SPECT/CT imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with a history of breast cancer treatment including axillary lymph node dissection (ALND) more than 2 years prior to study participation, who did not develop lymphedema.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lymphatic pathway anatomy of the upper extremity
Time frame: Study Visit 1: Immediately after ICG lymphography injections
Indocyanine green (ICG) lymphography of bilateral upper arms
Lymphatic pathway anatomy of the upper extremity
Time frame: Study Visit 1: 30 min after lymphoscintigraphy tracer injection
Lymphoscintigraphy scans of bilateral upper arms
Lymphatic pathway anatomy of the upper extremity
Time frame: Study Visit 1: 2 hours after lymphoscintigraphy tracer injection
Lymphoscintigraphy scans of bilateral upper arms
Lymphatic pathway anatomy of the upper extremity (SPECT/CT)
Time frame: Study Visit 1: 2 hours after lymphoscintigraphy tracer injection
SPECT/CT lymphoscintigraphy scans of bilateral upper arms
Lymphatic pathway anatomy of the upper extremity
Time frame: Study Visit 2: 30 min after lymphoscintigraphy tracer injection
Lymphoscintigraphy scans of bilateral upper arms
Lymphatic pathway anatomy of the upper extremity
Time frame: Study Visit 2: 2 hours after lymphoscintigraphy tracer injection
Lymphoscintigraphy scans of bilateral upper arms
Lymphatic pathway anatomy of the upper extremity (SPECT/CT)
Time frame: Study Visit 2: 2 hours after lymphoscintigraphy tracer injection
SPECT/CT lymphoscintigraphy scans of bilateral upper arms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dhruv Singhal, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphatic System, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Chen, BS (6176327043, achen22@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphatic pathway anatomy of the upper extremity (time frame: Study Visit 1: Immediately after ICG lymphography injections). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.