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Completed

NCT Number: NCT06024213

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CH Annecy-Genevois, Annecy, Epagny Metz-Tessy, Haute-Savoie, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Sentinel lymph node identification

Procedure

Intervention description: Intraoperative identification of sentinel lymph node

Indocyanine green

Drug

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 Blue

Drug

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

Primary outcomes

  1. Sentinel lymph node detection rate

    Time frame: Time of Surgery

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

Secondary outcomes

  1. Age

    Time frame: At visit 1 (pre-operative consultation)

    Patient age

  2. Height

    Time frame: At visit 1 (pre-operative consultation)

    Patient height

  3. Weight

    Time frame: At visit 1 (pre-operative consultation)

    Patient weight

  4. BMI

    Time frame: At visit 1 (pre-operative consultation)

    Patient BMI

  5. Comorbidities

    Time frame: At visit 1 (pre-operative consultation)

    Comorbidities of interest

  6. Menopause status

    Time frame: At visit 1 (pre-operative consultation)

    Menopause status

  7. Prior excisional surgery

    Time frame: At visit 1 (pre-operative consultation)

    Prior excisional surgery on the breast

  8. Surgery type planned

    Time frame: At visit 1 (pre-operative consultation)

    Type of breast surgery planned

  9. Tumour size

    Time frame: At visit 1 (pre-operative consultation)

    Tumour size

  10. Tumour grade

    Time frame: At visit 1 (pre-operative consultation)

    Tumour grade

  11. Tumour stage

    Time frame: At visit 1 (pre-operative consultation)

    Tumour stage

  12. Histological type

    Time frame: At visit 1 (pre-operative consultation)

    Tumour histological type

  13. Hormone receptor status

    Time frame: At visit 1 (pre-operative consultation)

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

  14. Tumour laterality

    Time frame: At visit 1 (pre-operative consultation)

    Tumour laterality

  15. Tumour quadrant

    Time frame: At visit 1 (pre-operative consultation)

    Tumour quadrant

  16. Detection method

    Time frame: Time of surgery

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

  17. Indocyanine green dose

    Time frame: Time of surgery

    Dose of indocyanine green

  18. Indocyanine green volume

    Time frame: Time of surgery

    Volume of indocyanine green

  19. Injection site

    Time frame: Time of surgery

    Description of injection site

  20. Number of injection sites

    Time frame: Time of surgery

    Number of injection sites

  21. Route of injection

    Time frame: Time of surgery

    Route of injection (periareolar or peritumoural)

  22. Detection equipment

    Time frame: Time of surgery

    Equipment used for detection of sentinel lymph node

  23. Number of sentinel lymph node biopsies performed

    Time frame: Time of surgery

    Number of sentinel lymph node biopsies performed

  24. Time from injection to visualization

    Time frame: Time of surgery

    Time from injection to visualization of first sentinel lymph node

  25. Time from injection to end of biopsy

    Time frame: Time of surgery

    Time from injection to end of biopsy procedure

  26. Number of sentinel lymph nodes detected

    Time frame: Time of surgery

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

  27. Number of sentinel lymph nodes detected - indocyanine green

    Time frame: Time of surgery

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

  28. Number of sentinel lymph nodes detected - blue dye

    Time frame: Time of surgery

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

  29. Number of sentinel lymph nodes detected - 99mTc

    Time frame: Time of surgery

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

  30. Adverse events

    Time frame: From time of surgery up to 6 weeks post-surgery

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

  31. Serious adverse events

    Time frame: From time of surgery up to 6 weeks post-surgery

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

  32. Changes in vital signs

    Time frame: From time of surgery up to 6 weeks post-surgery

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

Other outcomes

  1. Sentinel lymph node detection rate by obesity status

    Time frame: Time of surgery

    Rate of detection of at least one sentinel lymph node by indocyanine green in obese (BMI ≥30 kg/m2) vs non-obese (BMI ≤30 kg/m2) patients

  2. Sentinel lymph node detection rate in early-stage breast cancer

    Time frame: Time of surgery

    Rate of detection of at least one sentinel lymph node by indocyanine green in patients with stage 1A, 1B, or 2A breast cancer

  3. Sentinel lymph node detection rate by indocyanine green dose

    Time frame: Time of surgery

    Rate of detection of at least one sentinel lymph node by indocyanine green for patients receiving 5 mg dose vs 10 mg dose

  4. Sentinel lymph node detection rate by injection route

    Time frame: Time of surgery

    Rate of detection of at least one sentinel lymph node by indocyanine green for patients injected via periareolar vs peritumoural vs subcutaneous route

Sponsors and collaborators

Lead sponsor

BTG International Inc.

Other

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study 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.

Acronym: OASIS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2023
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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