Breast CancerARMONICNCT02994225
Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity
A study testing Indocyanine Green in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes is of paramount importance in the subsequent management of this cancer and surgery of invasive breast cancer (BC) involves axillary lymph node dissection (ALND). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2017to 5 Aug 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over 18 years of age
- Preoperative diagnosis of Invasive breast cancer
- Patient deemed for total mastectomy with axillary lymph node dissection (ALND)
- Subject capable of giving informed consent and participating in the process of consent
- Affiliated to the french social security
Who cannot join
- Mastectomy without ALND
- Previous ipsilateral axillary radiotherapy
- Previous axillary surgery
- Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
- Breastfeeding
- Allergy to indocyanine green
Show all 10Show fewer
- Patients with a known history of reaction to iodine or iodine-containing compounds.
- No consent
- Impaired capacity to make informed medical decisions
- Patient on guardianship
Trial locations and contacts
1 site in 1 country.
About this study
The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes is of paramount importance in the subsequent management of this cancer and surgery of invasive breast cancer (BC) involves axillary lymph node dissection (ALND). To preserve arm lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is uncertain.
The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of draining lymphatics. The project aims to train surgeons to the technique and to identify predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary pathological parameters to better select patients who would not require removal of the ARM node in the future
- Conditions
- Breast Cancer
- Being tested
- Indocyanine Green
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Subcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery.
Near Infra-red images acquisition is performed during surgery
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Subcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery.
Near Infra-red images acquisition is performed during surgery Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of identification
To determine the Rate of identification of reverse axillary node using Indocyanine green (ICG) and near-infrared (NIR) imaging in invasive breast cancer that undergo total mastectomy and ALND.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start10 Mar 2017
- Primary completion7 Jun 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chafika MAZOUNI, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994225
- Sponsor's protocol ID
- 2016-A01623-48
- Other IDs
- 2016/2462
- Acronym
- ARMONIC
- Status last verified
- May 2022
- First submitted
- 13 Dec 2016
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conversano A, Abbaci M, Karimi M, Mathieu MC, de Leeuw F, Michiels S, Laplace-Builhe C, Mazouni C. Axillary reverse mapping using near-infrared fluorescence imaging in invasive breast cancer (ARMONIC study). Eur J Surg Oncol. 2022 Dec;48(12):2393-2400. doi: 10.1016/j.ejso.2022.07.004. Epub 2022 Jul 8.
PubMed 35840448Abbaci M, Conversano A, Karimi M, Mathieu MC, Rouffiac V, De Leeuw F, Michiels S, Laplace-Builhe C, Mazouni C. Near-Infrared Fluorescence Axillary Reverse Mapping (ARM) Procedure in Invasive Breast Cancer: Relationship between Fluorescence Signal in ARM Lymph Nodes and Clinical Outcomes. Cancers (Basel). 2022 May 25;14(11):2614. doi: 10.3390/cancers14112614.
PubMed 35681595
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity
- ClinicalTrials.gov ID
- NCT02994225
- Acronym / sponsor ID
- ARMONIC / 2016-A01623-48
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 15 Dec 2016 (estimated)
- 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 initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes is of paramount importance in the subsequent management of this cancer and surgery of invasive breast cancer (BC) involves axillary lymph node dissection (ALND). To preserve arm lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is uncertain.
The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of draining lymphatics. The project aims to train surgeons to the technique and to identify predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary pathological parameters to better select patients who would not require removal of the ARM node in the future
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: Indocyanine GreenSubcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery. Near Infra-red images acquisition is performed during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients over 18 years of age
- Preoperative diagnosis of Invasive breast cancer
- Patient deemed for total mastectomy with axillary lymph node dissection (ALND)
- Subject capable of giving informed consent and participating in the process of consent
- Affiliated to the french social security
Key exclusion criteria (10 listed)
- Mastectomy without ALND
- Previous ipsilateral axillary radiotherapy
- Previous axillary surgery
- Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
- Breastfeeding
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 |
|---|---|---|
| Indocyanine GreenSubcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery. Near Infra-red images acquisition is performed during surgery | Drug | Study arm |
Primary outcome
Rate of identification
Time frame: up to 30 days
To determine the Rate of identification of reverse axillary node using Indocyanine green (ICG) and near-infrared (NIR) imaging in invasive breast cancer that undergo total mastectomy and ALND.
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 16 May 2022.
- Derived from this study: PubMed 35840448Conversano A, Abbaci M, Karimi M, Mathieu MC, de Leeuw F, Michiels S, Laplace-Builhe C, Mazouni C. Axillary reverse mapping using near-infrared fluorescence imaging in invasive breast cancer (ARMONIC study). Eur J Surg Oncol. 2022 Dec;48(12):2393-2400. doi: 10.1016/j.ejso.2022.07.004. Epub 2022 Jul 8.
- Derived from this study: PubMed 35681595Abbaci M, Conversano A, Karimi M, Mathieu MC, Rouffiac V, De Leeuw F, Michiels S, Laplace-Builhe C, Mazouni C. Near-Infrared Fluorescence Axillary Reverse Mapping (ARM) Procedure in Invasive Breast Cancer: Relationship between Fluorescence Signal in ARM Lymph Nodes and Clinical Outcomes. Cancers (Basel). 2022 May 25;14(11):2614. doi: 10.3390/cancers14112614.
- 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.
Chafika MAZOUNI, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 5 inclusion and 10 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 16 May 2022. 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 France. 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 identification (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02994225, which also lists 2 linked publications.
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 16 May 2022.