Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
10
Countries
1
Sites
1
Breast Cancer
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]
Key facts
- Sponsor
- Centro Di Riferimento Oncologico Di Aviano
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Dec 2024 → ongoing
- Decision date (initial)
- 2024-10-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513163-57-00
- ClinicalTrials.gov
- NCT06347354
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
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]
Secondary objectives 4
- Identification of the total number of fluorescent lymph nodes
- Differences in the qualitative assessment (intensity) of fluorescence between the removed lymph nodes: lymph nodes will be divided into group A "intense fluorescence" and group B "mild fluorescence"
- Association between histological positivity for metastases in sentinel and non-sentinel lymph nodes
- Association between the patient's demographic/clinical variables and the presence or absence of fluorescent lymph nodes
Conditions and MedDRA coding
Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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.
Exclusion criteria 6
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Frequency of patient with at least 3 fluorescent lymph nodes
Secondary endpoints 4
- Absolute frequency of total number of fluorescent lymph nodes per patient
- Absolute frequency of lymph nodes in group A and in group B
- Frequency of lymph nodes with metastases resulting fluorescent
- Frequency of fluorescent and non-fluorescent lymph nodes between subgroups of patients with different demographic and clinical characteristics
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP2006725 · ATC
- Active substance
- Indocyanine Green
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CX01 — INDOCYANINE GREEN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centro Di Riferimento Oncologico Di Aviano
- Sponsor organisation
- Centro Di Riferimento Oncologico Di Aviano
- Address
- Via Franco Gallini 2
- City
- Aviano
- Postcode
- 33081
- Country
- Italy
Scientific contact point
- Organisation
- Centro Di Riferimento Oncologico Di Aviano
- Contact name
- Stefano Fracon
Public contact point
- Organisation
- Centro Di Riferimento Oncologico Di Aviano
- Contact name
- Stefano Fracon
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2024-12-20 | 2025-03-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 23 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | FLUO_Protocol_v2_28Aug2024 | 2.0 |
| Protocol (for publication) | FLUO_Protocol_v2_28Aug2024_tc | 2 |
| Protocol (for publication) | FLUO_Protocol_v3_16Dec2025 | 3.0 |
| Protocol (for publication) | FLUO_Protocol_v3_16Dec2025_tc | 3 |
| Recruitment arrangements (for publication) | FLUO_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | FLUO_Informativa e consenso | 3.0 |
| Subject information and informed consent form (for publication) | FLUO_Informativa e consenso al trattamento dati | 2 |
| Subject information and informed consent form (for publication) | FLUO_Informativa e consenso al trattamento dati v3_16Dec2025 | 3.0 |
| Subject information and informed consent form (for publication) | FLUO_Informativa e consenso al trattamento dati v3_16Dec2025_fp | 3 |
| Subject information and informed consent form (for publication) | FLUO_Informativa e consenso al trattamento dati v3_16Dec2025_tc | 3 |
| Subject information and informed consent form (for publication) | FLUO_Informativa e consenso_v4_16Dec2025 | 4.0 |
| Subject information and informed consent form (for publication) | FLUO_Informativa e consenso_v4_16Dec2025_fp | 4 |
| Subject information and informed consent form (for publication) | FLUO_Informativa e consenso_v4_16Dec2025_tc | 4 |
| Subject information and informed consent form (for publication) | FLUO_Lettera al MMG_v1_22May2024 | 1 |
| Subject information and informed consent form (for publication) | FLUO_Lettera al MMG_v2_16Dec2025 | 2.0 |
| Subject information and informed consent form (for publication) | FLUO_Lettera al MMG_v2_16Dec2025_fp | 2 |
| Subject information and informed consent form (for publication) | FLUO_Lettera al MMG_v2_16Dec2025_tc | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Verde di Indocianina_estensione di indicazione | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Verdye_RCP | 1 |
| Synopsis of the protocol (for publication) | FLUO_Sinossi_v2_28Aug2024 | 2.0 |
| Synopsis of the protocol (for publication) | FLUO_Sinossi_v2_28Aug2024_tc | 2 |
| Synopsis of the protocol (for publication) | FLUO_Sinossi_v3_16Dec2025 | 3.0 |
| Synopsis of the protocol (for publication) | FLUO_Sinossi_v3_16Dec2025_tc | 3 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-01 | Italy | Acceptable 2024-10-03
|
2024-10-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-16 | Italy | Acceptable 2026-03-03
|
2026-03-09 |