Authorised Therapeutic exploratory (Phase II) Breast Cancer

Permanence of Indocyanine Green in axillary lymph nodes three weeks after subdermal injection in patients with Breast Carcinoma and metastatic lymph nodes: The FLUO Trial

EU CTIS ID: 2024-513163-57-00

What this study is testing

Permanence of fluorescence at the level of axillary lymph nodes at 2-3 weeks after subcutaneous injection of Indocyanine Green (2.5 mg), in patients who will undergo radical axillary surgery [Time Frame: up to 3 weeks]

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Written informed consent prior to beginning any protocol specific procedure during treatment and follow up, according to regulatory requirements.
  • Age equal to or higher than 18 years
  • Patients affeted by breast cancer with cyto-histological confirmation of lymph node metastases and eligible for quadrantectomy/mastectomy combined with radical axillary surgery.

You likely can't join if

  • Allergy to iodium or Indocyanine Green
  • Presence of Thyroid disorders (hyperthyroidism, autoimmune thyroid adenomas)
  • Patients not eligible for radical axillary surgery
  • Patient in a state of pregnancy
  • Under the age of 18 years
  • Non-autonomous patient or in need of a legal representative

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.