Lymph Node Cancer MetastaticARMNCT05040685
Axillary Reverse Mapping in Breast Cancer
A study testing Axillary mapping reverse in people with Lymph Node Cancer Metastatic, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The axillary mapping reverse (ARM) consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymph Node Cancer Metastatic
- What is being tested?
- Axillary mapping reverse
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who will undergo ALND in the treatment of breast cancer:
- cT4a, cT4c and cT4d.
- cT4b with extensive involvement of the skin.
- cN0 with SLNB positive (pN+) that need to associate ALND:
- cT3-T4b.
- >2 lymph node macrometastasis if cTis, cT1 and cT2.
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- Patients who underwent mastectomy and it is not possible associate adjuvant radiotherapy.
- cN1:
- If primary surgery treatment.
- After neoadjuvant systemic treatment, if there is not a clinical-radiological complete response and/or SLNB positive (ypN+).
- cN2:
- If primary surgery treatment.
- After neoadjuvant systemic treatment, if luminal tumours or there is not a clinical-radiological complete response in triple negative or HER2 overexpressed tumours.
- cN3.
Who cannot join
- Patients with previous axillary surgery (except sentinel node biopsy)
- Patients who did previous axillary radiotherapy treatment.
- Patients who do not wish to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Axillary Reverse Mapping (ARM): Validation of Surgical Tecnique in Breast Cancer Surgery
The axillary mapping reverse (ARM) consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.
A significant decrease of lymphedema rates in patients who was possible associate ARM technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques like fluorescence dye.
Read the detailed description
Axillary lymph node dissection (ALND) was the standard therapy until 1990-2000, when the technique was replaced, when possible, by another procedure associated with less morbidity: the sentinel lymph node biopsy (SLNB). However, actually, ALND is still the gold standard in some patients. This procedure is associated with substantial morbidity, like lymphedema, shoulder pain, arm numbness, axillary web syndrome and decreased upper-extremity range of motion (ROM), that severely conditions the quality of life of these patients.
In 2007, the investigators had the first reports about a new surgical technique, the axillary mapping reverse (ARM), that consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.
The current literature shows a significant decrease of lymphedema rates in patients who was possible associate this technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques. With the use of indocyanine green, the visualisation rates in the axilla of ARM lymphatics are from 88%, similar to other techniques. Some advantages of fluorescence dye are that no systemic allergic reactions have been reported and the 'green tattoo' disappears quickly.
HYPHOTESIS The axillary mapping reverse (AMR) is able to identify the lymph nodes responsible for lymphatic drainage of the ipsilateral upper limb (ARM nodes) in breast cancer patients who underwent an axillar lymph node dissection.
- Conditions
- Lymph Node Cancer Metastatic
- Being tested
- Axillary mapping reverse
- Keywords
- Lymphedema, Sentinel lymph node, Axillary lymph node dissection
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary mapping reverseProcedure or surgery
At the time of performing the ALND associate the ARM, injecting between 2-5mL of indocyanine green subcutaneously in the ipsilateral upper extremity at the medial inter-muscular and massaged for 5 min. First, identify the ARM nodes by indocyanine green, then perform conventional axillary lymphadenectomy trying to preserve the ARM nodes. And, in a second time, extract ARM nodes for their individualized anatomopathological study.
| Study group | Role | What they receive |
|---|---|---|
| Axillary mapping reverse | Experimental | Application of axillary mapping reverse technique Receives: Procedure: Axillary mapping reverse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who it is possible preserve ARM nodes
Determinate the percentage of patients who is possible preserve the ARM node during ALND
Measured: 1 year
Secondary outcomes (1)
Rate of metastatic ARM
Determinate the percentage of metastatic ARM nodes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Jun 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node Cancer MetastaticStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective not randomized pilot study to validate the axillary mapping reverse technique by using indocyanine green.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge
- Investigators
- Carlos Ortega Expósito, MD, Principal investigator, Bellvitge Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040685
- Sponsor's protocol ID
- PR139/21
- Acronym
- ARM
- Status last verified
- Feb 2024
- First submitted
- 19 Aug 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Reverse Mapping (ARM): Validation of Surgical Tecnique in Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT05040685
- Acronym / sponsor ID
- ARM / PR139/21
- Conditions
- Lymph Node Cancer Metastatic
- Keywords
- Lymphedema, Sentinel lymph node, Axillary lymph node dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 10 Sep 2021 (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.
The axillary mapping reverse (ARM) consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.
A significant decrease of lymphedema rates in patients who was possible associate ARM technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques like fluorescence dye.
Detailed description
Axillary lymph node dissection (ALND) was the standard therapy until 1990-2000, when the technique was replaced, when possible, by another procedure associated with less morbidity: the sentinel lymph node biopsy (SLNB). However, actually, ALND is still the gold standard in some patients. This procedure is associated with substantial morbidity, like lymphedema, shoulder pain, arm numbness, axillary web syndrome and decreased upper-extremity range of motion (ROM), that severely conditions the quality of life of these patients.
In 2007, the investigators had the first reports about a new surgical technique, the axillary mapping reverse (ARM), that consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.
The current literature shows a significant decrease of lymphedema rates in patients who was possible associate this technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques. With the use of indocyanine green, the visualisation rates in the axilla of ARM lymphatics are from 88%, similar to other techniques. Some advantages of fluorescence dye are that no systemic allergic reactions have been reported and the 'green tattoo' disappears quickly.
HYPHOTESIS The axillary mapping reverse (AMR) is able to identify the lymph nodes responsible for lymphatic drainage of the ipsilateral upper limb (ARM nodes) in breast cancer patients who underwent an axillar lymph node dissection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective not randomized pilot study to validate the axillary mapping reverse technique by using indocyanine green.
| Arm | Type | Receives |
|---|---|---|
| Axillary mapping reverse | Experimental | Procedure: Axillary mapping reverseApplication of axillary mapping reverse technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- cT4a, cT4c and cT4d.
- cT4b with extensive involvement of the skin.
- cN0 with SLNB positive (pN+) that need to associate ALND:
- cN1:
- cN2:
Key exclusion criteria (3 listed)
- Patients with previous axillary surgery (except sentinel node biopsy)
- Patients who did previous axillary radiotherapy treatment.
- Patients who do not wish to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axillary mapping reverseAt the time of performing the ALND associate the ARM, injecting between 2-5mL of indocyanine green subcutaneously in the ipsilateral upper extremity at the medial inter-muscular and massaged for 5 min. First, identify the ARM nodes by indocyanine green, then perform conventional axillary lymphadenectomy trying to preserve the ARM nodes. And, in a second time, extract ARM nodes for their individualized anatomopathological study. | Procedure or surgery | Axillary mapping reverse |
Primary outcome
Rate of patients who it is possible preserve ARM nodes
Time frame: 1 year
Determinate the percentage of patients who is possible preserve the ARM node during ALND
1 secondary outcome
Rate of metastatic ARM
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Carlos Ortega Expósito, MD principal investigator
Bellvitge Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary mapping reverse in people with Lymph Node Cancer Metastatic, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 14 inclusion and 3 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who it is possible preserve ARM nodes (time frame: 1 year). 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 28 Feb 2024.