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Breast CancerOASISNCT06024213

A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.

An observational study of Breast Cancer, run by BTG International Inc. at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective, observational study will evaluate the patient-based sentinel lymph node detection rate when using the Infracyanine® (indocyanine green) dye technique in patients undergoing surgery for breast cancer. 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?
Sentinel lymph node identification, indocyanine green and methylene blue
Type of treatment
Surgery or procedure
How many people
101 participants
Where
6 sitesFrance
Study dates
6 Jun 2023to 19 Dec 2023
Phase
Observational
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

Study population: The study will be conducted at French hospitals involved in the management of female patients with breast cancer where indocyanine green is used in routine practice. Patients will be enrolled from approximately 5 sites in metropolitan France.

Who may be able to join

  • Female
  • Aged ≥18 years
  • Undergoing breast cancer surgery with an indication for sentinel lymph node biopsy
  • Receiving Infracyanine® (indocyanine green; alone or in combination with blue dye or 99mTc) for intraoperative identification of sentinel lymph node according to the Summary of Product Characteristics

Who cannot join

  • Male
  • Pregnant or nursing female
  • Previous allergy to indocyanine green or to any excipients
  • Already included in a surgical trial
  • Patient opposed to collection and processing of their data

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • CH Annecy-Genevois

    Annecy, Epagny Metz-Tessy, Haute-Savoie, 74370

  • Institut Bergonié

    Bordeaux, Gironde, 33000

  • CHU de Lille

    Lille, Nord, 59000

  • Hôpital Européen Georges-Pompidou Paris

    Paris, Île-de-France Region, 75015

  • CHU de Saint-Etienne

    Saint-Étienne-de-Montluc, Pays de la Loire Region, 42100 France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

Other trials in France

About this study

Official title: French, Prospective, Post-marketing Study to Describe the Use, Detection Performance and Safety Profile of Infracyanine® (Indocyanine Green) for Breast Cancer Patients Undergoing a Sentinel Lymph Node (SLN) Biopsy.

This prospective, observational study will evaluate the patient-based sentinel lymph node detection rate when using the Infracyanine® (indocyanine green) dye technique in patients undergoing surgery for breast cancer.

The study will describe the demographic, clinical, and tumour characteristics of patients with breast cancer undergoing surgery.

Read more

The study will describe the characteristics of how the indocyanine green dye technique is used including the dose and volume of dye used, the number and type of injection sites used to give the dye, the equipment used to detect the dye and locate the sentinel lymph node, and whether indocyanine green is used on its own or with other dyes (blue dye and/or 99mTechnetium dye).

The study will evaluate the characteristics of sentinel lymph node biopsy procedures performed using indocyanine green dye including the number of biopsies performed, the time taken to detect the sentinel lymph node and perform the biopsy, and how many sentinel lymph nodes are detected using indocyanine green dye, blue dye, and 99mTechnetium dye.

The study will also assess the safety of using indocyanine green dye for 6 weeks following surgery.

Conditions
Breast Cancer
Being tested
Sentinel lymph node identification, indocyanine green, methylene blue, Technetium (99mTc)
Keywords
sentinel lymph node biopsy, indocyanine green biopsy, fluorescence blue dye, technetium99
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sentinel lymph node identificationProcedure or surgery

    Intervention description: Intraoperative identification of sentinel lymph node

  • indocyanine greenDrug

    Intervention description: indocyanine green (5 to 10 mg [ie, 2 to 4 mL of a 2.5 mg/mL solution]) administered by periareolar or peritumoural route

  • methylene blueDrug

    1%), 2-5 mL administered by periareolar or peritumoural route

  • Technetium (99mTc)Drug

    (99mTc, 0.2 - 0.4 mCi in 0.4 mL administered by periareolar or peritumoural route

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sentinel lymph node detection rate

    Rate of detection of at least one sentinel lymph node by indocyanine green

    Measured: Time of Surgery

Secondary outcomes (32)

  1. Age

    Patient age

    Measured: At visit 1 (pre-operative consultation)

  2. Height

    Patient height

    Measured: At visit 1 (pre-operative consultation)

  3. Weight

    Patient weight

    Measured: At visit 1 (pre-operative consultation)

  4. BMI

    Patient BMI

    Measured: At visit 1 (pre-operative consultation)

  5. Comorbidities

    Comorbidities of interest

    Measured: At visit 1 (pre-operative consultation)

  6. Menopause status

    Menopause status

    Measured: At visit 1 (pre-operative consultation)

  7. Prior excisional surgery

    Prior excisional surgery on the breast

    Measured: At visit 1 (pre-operative consultation)

  8. Surgery type planned

    Type of breast surgery planned

    Measured: At visit 1 (pre-operative consultation)

  9. Tumour size

    Tumour size

    Measured: At visit 1 (pre-operative consultation)

  10. Tumour grade

    Tumour grade

    Measured: At visit 1 (pre-operative consultation)

  11. Tumour stage

    Tumour stage

    Measured: At visit 1 (pre-operative consultation)

  12. Histological type

    Tumour histological type

    Measured: At visit 1 (pre-operative consultation)

  13. Hormone receptor status

    Tumour hormone receptor status (estrogen receptors, progesterone receptors, and HER2 status)

    Measured: At visit 1 (pre-operative consultation)

  14. Tumour laterality

    Tumour laterality

    Measured: At visit 1 (pre-operative consultation)

  15. Tumour quadrant

    Tumour quadrant

    Measured: At visit 1 (pre-operative consultation)

  16. Detection method

    Method used to detect sentinel lymph node (indocyanine green alone or in combination with blue dye or 99mTc)

    Measured: Time of surgery

  17. Indocyanine green dose

    Dose of indocyanine green

    Measured: Time of surgery

  18. Indocyanine green volume

    Volume of indocyanine green

    Measured: Time of surgery

  19. Injection site

    Description of injection site

    Measured: Time of surgery

  20. Number of injection sites

    Number of injection sites

    Measured: Time of surgery

  21. Route of injection

    Route of injection (periareolar or peritumoural)

    Measured: Time of surgery

  22. Detection equipment

    Equipment used for detection of sentinel lymph node

    Measured: Time of surgery

  23. Number of sentinel lymph node biopsies performed

    Number of sentinel lymph node biopsies performed

    Measured: Time of surgery

  24. Time from injection to visualization

    Time from injection to visualization of first sentinel lymph node

    Measured: Time of surgery

  25. Time from injection to end of biopsy

    Time from injection to end of biopsy procedure

    Measured: Time of surgery

  26. Number of sentinel lymph nodes detected

    Number of sentinel lymph nodes detected (by all detection methods) per patient

    Measured: Time of surgery

  27. Number of sentinel lymph nodes detected - indocyanine green

    Number of sentinel lymph nodes detected (by indocyanine green) per patient

    Measured: Time of surgery

  28. Number of sentinel lymph nodes detected - blue dye

    Number of sentinel lymph nodes detected (by blue dye) per patient

    Measured: Time of surgery

  29. Number of sentinel lymph nodes detected - 99mTc

    Number of sentinel lymph nodes detected (by 99mTc) per patient

    Measured: Time of surgery

  30. Adverse events

    Number, frequency, grade, and outcomes of adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA

    Measured: From time of surgery up to 6 weeks post-surgery

  31. Serious adverse events

    Number frequency, and outcomes of serious adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA

    Measured: From time of surgery up to 6 weeks post-surgery

  32. Changes in vital signs

    Number of observed clinically significant changes in blood pressure, pulse rate, and respiratory rate

    Measured: From time of surgery up to 6 weeks post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2023
  2. Study start6 Jun 2023
  3. Primary completion6 Nov 2023
  4. Study completion19 Dec 2023

Resources

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
Case only
Time perspective
Prospective
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06024213
Sponsor's protocol ID
PR024-CLN-pro101
Acronym
OASIS
Status last verified
Sep 2023
First submitted
29 Aug 2023
Last updated
10 May 2024
Results posted
No

Publications

  • Vermersch C, Raia-Barjat T, Chapelle C, Lima S, Chauleur C. Randomized comparison between indocyanine green fluorescence plus 99mtechnetium and 99mtechnetium alone methods for sentinel lymph node biopsy in breast cancer. Sci Rep. 2019 May 6;9(1):6943. doi: 10.1038/s41598-019-43473-3.

    PubMed 31061432

  • Guo J, Yang H, Wang S, Cao Y, Liu M, Xie F, Liu P, Zhou B, Tong F, Cheng L, Liu H, Wang S. Comparison of sentinel lymph node biopsy guided by indocyanine green, blue dye, and their combination in breast cancer patients: a prospective cohort study. World J Surg Oncol. 2017 Nov 2;15(1):196. doi: 10.1186/s12957-017-1264-7.

    PubMed 29096643

  • Kitai 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 16110291

  • Sugie T, Kinoshita T, Masuda N, Sawada T, Yamauchi A, Kuroi K, Taguchi T, Bando H, Yamashiro H, Lee T, Shinkura N, Kato H, Ikeda T, Yoshimura K, Ueyama H, Toi M. Evaluation of the Clinical Utility of the ICG Fluorescence Method Compared with the Radioisotope Method for Sentinel Lymph Node Biopsy in Breast Cancer. Ann Surg Oncol. 2016 Jan;23(1):44-50. doi: 10.1245/s10434-015-4809-4. Epub 2015 Aug 15.

    PubMed 26275781

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by BTG International Inc. at 6 sites 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 4 inclusion and 5 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

Sentinel lymph node detection rate (time frame: Time of Surgery). 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 NCT06024213, which also lists 4 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 10 May 2024.

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