Breast CancerINSEANNCT06378944
Selective Sentinella Lymph Node Biopsy with Indocyanine Green in Patients with Breast Cancer
An observational study of Breast Cancer, run by Omphis Foundation at 1 site in Spain.
Trial summary
The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Application of green indocyanine colorant and Technetium99
- How many people
- 15,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 1 Jan 2029
- How long will I take part?
- 2 Years
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with breast cancer who recieve surgery and required to perform lymph node detection
Who may be able to join
- Patients >18 years of age with breast cancer who are candidates for sentinel lymph node detection will be included.
- N0 patients or patients who have undergone target axillary detection with good response
Who cannot join
- Lymphadenectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Sandra Lopez Gordo
Cerdanyola del Vallès, Barcelona, 08290
Sandra Lopez gordo, 660284047, sandra.lopezgordo@gmail.com
About this study
Official title: INDOCYANINE GREEN for SELECTIVE SENTINELLA AXILLARY LYMPH NODE BIOPSY in PATIENTS with BREAST CANCER
The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique.
Read the detailed description
In the operating room 1 ml of indocyaninge grenn will be injectec periareolar . After 5 minutes the lymph node will be detected and extracted. The comparison between the lymph nodes detected with Technetium 99 and indocyanine green will be analysed.
- Conditions
- Breast Cancer
- Being tested
- Application of green indocyanine colorant, Technetium99
- Keywords
- lymph node detection, indocyanine green, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of green indocyanine colorantOther
The day of the surgery 1 ml of green indocyanine colorant will be applicated periareolar. After 5 minutes the lymph node will be detected and extracted
Technetium99Drug
Application of a periareolar injectionof TEchnetium 99 in order to detect the axillary lymph node
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Sentinel lymph node detected. Scale of numbers
Number of lymph node detected with Indocyanine green and number of lymph node detected iwth techetium 99. Scale of numbers
Measured: patients included from 1 January of 2024 til January 1 2029
Secondary outcomes (2)
Number of possitive lymph nodes
assess whether there are differences in affected lymph nodes detected with indocyanine green or technetium 99 Number of possitive lymph nodes iwh indocyanine green and with technetium 99
Measured: patients included from 1 January of 2024 til January 1 2029
surgery time in minutes
Time in minutes from skin incision to lymp node removal.
Measured: patients included from 1 January of 2024 til January 1 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Omphis Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Lopez Gordo, Omphis Foundation
- Investigators
- Sandra Lopez gordo, Study director, 46873584K
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378944
- Sponsor's protocol ID
- 61/23
- Acronym
- INSEAN
- Status last verified
- Sep 2024
- First submitted
- 1 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krag DN, Weaver DL, Alex JC, Fairbank JT. Surgical resection and radiolocalization of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol. 1993 Dec;2(6):335-9; discussion 340. doi: 10.1016/0960-7404(93)90064-6.
PubMed 8130940Giuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surg. 1994 Sep;220(3):391-8; discussion 398-401. doi: 10.1097/00000658-199409000-00015.
PubMed 8092905Goyal A, Newcombe RG, Chhabra A, Mansel RE; ALMANAC Trialists Group. Factors affecting failed localisation and false-negative rates of sentinel node biopsy in breast cancer--results of the ALMANAC validation phase. Breast Cancer Res Treat. 2006 Sep;99(2):203-8. doi: 10.1007/s10549-006-9192-1. Epub 2006 Mar 16.
PubMed 16541308Kitai T, Inomoto T, Miwa M, Shikayama T. Fluorescence navigation with indocyanine green for detecting sentinel lymph nodes in breast cancer. Breast Cancer. 2005;12(3):211-5. doi: 10.2325/jbcs.12.211.
PubMed 16110291Jeremiasse B, van den Bosch CH, Wijnen MWHA, Terwisscha van Scheltinga CEJ, Fiocco MF, van der Steeg AFW. Systematic review and meta-analysis concerning near-infrared imaging with fluorescent agents to identify the sentinel lymph node in oncology patients. Eur J Surg Oncol. 2020 Nov;46(11):2011-2022. doi: 10.1016/j.ejso.2020.07.012. Epub 2020 Aug 3.
PubMed 32826112Goonawardena J, Yong C, Law M. Use of indocyanine green fluorescence compared to radioisotope for sentinel lymph node biopsy in early-stage breast cancer: systematic review and meta-analysis. Am J Surg. 2020 Sep;220(3):665-676. doi: 10.1016/j.amjsurg.2020.02.001. Epub 2020 Feb 7.
PubMed 32115177Kedrzycki MS, Leiloglou M, Ashrafian H, Jiwa N, Thiruchelvam PTR, Elson DS, Leff DR. Meta-analysis Comparing Fluorescence Imaging with Radioisotope and Blue Dye-Guided Sentinel Node Identification for Breast Cancer Surgery. Ann Surg Oncol. 2021 Jul;28(7):3738-3748. doi: 10.1245/s10434-020-09288-7. Epub 2020 Nov 6.
PubMed 33156466
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INDOCYANINE GREEN for SELECTIVE SENTINELLA AXILLARY LYMPH NODE BIOPSY in PATIENTS with BREAST CANCER
- ClinicalTrials.gov ID
- NCT06378944
- Acronym / sponsor ID
- INSEAN / 61/23
- Conditions
- Breast Cancer
- Keywords
- lymph node detection, indocyanine green, breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Omphis FoundationUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 23 Apr 2024 (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 current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique.
Detailed description
In the operating room 1 ml of indocyaninge grenn will be injectec periareolar . After 5 minutes the lymph node will be detected and extracted. The comparison between the lymph nodes detected with Technetium 99 and indocyanine green will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with breast cancer who recieve surgery and required to perform lymph node detection
Key inclusion criteria (2 listed)
- Patients >18 years of age with breast cancer who are candidates for sentinel lymph node detection will be included.
- N0 patients or patients who have undergone target axillary detection with good response
Key exclusion criteria (1 listed)
- Lymphadenectomy
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 |
|---|---|---|
| Application of green indocyanine colorantThe day of the surgery 1 ml of green indocyanine colorant will be applicated periareolar. After 5 minutes the lymph node will be detected and extracted | Other | – |
| Technetium99Application of a periareolar injectionof TEchnetium 99 in order to detect the axillary lymph node | Drug | – |
Primary outcome
Number of Sentinel lymph node detected. Scale of numbers
Time frame: patients included from 1 January of 2024 til January 1 2029
Number of lymph node detected with Indocyanine green and number of lymph node detected iwth techetium 99. Scale of numbers
2 secondary outcomes
Number of possitive lymph nodes
Time frame: patients included from 1 January of 2024 til January 1 2029
surgery time in minutes
Time frame: patients included from 1 January of 2024 til January 1 2029
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 19 Sep 2024.
- Background: PubMed 8130940Krag DN, Weaver DL, Alex JC, Fairbank JT. Surgical resection and radiolocalization of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol. 1993 Dec;2(6):335-9; discussion 340. doi: 10.1016/0960-7404(93)90064-6.
- Background: PubMed 8092905Giuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surg. 1994 Sep;220(3):391-8; discussion 398-401. doi: 10.1097/00000658-199409000-00015.
- Background: PubMed 16541308Goyal A, Newcombe RG, Chhabra A, Mansel RE; ALMANAC Trialists Group. Factors affecting failed localisation and false-negative rates of sentinel node biopsy in breast cancer--results of the ALMANAC validation phase. Breast Cancer Res Treat. 2006 Sep;99(2):203-8. doi: 10.1007/s10549-006-9192-1. Epub 2006 Mar 16.
- Background: PubMed 16110291Kitai T, Inomoto T, Miwa M, Shikayama T. Fluorescence navigation with indocyanine green for detecting sentinel lymph nodes in breast cancer. Breast Cancer. 2005;12(3):211-5. doi: 10.2325/jbcs.12.211.
- Background: PubMed 32826112Jeremiasse B, van den Bosch CH, Wijnen MWHA, Terwisscha van Scheltinga CEJ, Fiocco MF, van der Steeg AFW. Systematic review and meta-analysis concerning near-infrared imaging with fluorescent agents to identify the sentinel lymph node in oncology patients. Eur J Surg Oncol. 2020 Nov;46(11):2011-2022. doi: 10.1016/j.ejso.2020.07.012. Epub 2020 Aug 3.
- Background: PubMed 32115177Goonawardena J, Yong C, Law M. Use of indocyanine green fluorescence compared to radioisotope for sentinel lymph node biopsy in early-stage breast cancer: systematic review and meta-analysis. Am J Surg. 2020 Sep;220(3):665-676. doi: 10.1016/j.amjsurg.2020.02.001. Epub 2020 Feb 7.
- Background: PubMed 33156466Kedrzycki MS, Leiloglou M, Ashrafian H, Jiwa N, Thiruchelvam PTR, Elson DS, Leff DR. Meta-analysis Comparing Fluorescence Imaging with Radioisotope and Blue Dye-Guided Sentinel Node Identification for Breast Cancer Surgery. Ann Surg Oncol. 2021 Jul;28(7):3738-3748. doi: 10.1245/s10434-020-09288-7. Epub 2020 Nov 6.
- 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.
Sandra Lopez gordo study director
46873584K
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 Breast Cancer, run by Omphis Foundation 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 2 inclusion and 1 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 19 Sep 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?
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 Sandra Lopez gordo (0034660284047, sandra.lopezgordo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Sentinel lymph node detected. Scale of numbers (time frame: patients included from 1 January of 2024 til January 1 2029). 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 NCT06378944, which also lists 7 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 19 Sep 2024.