ICG-fluorescence imaging for intraoperative breast cancer margins evaluation: a dose-timing study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut Jules Bordet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

9 Feb 2024 → ongoing

Decision date (initial)

2023-12-15

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Association Jules Bordet · Diagnostic Green LLC

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To select the best strategy (timing for imaging and ICG dose) for surgical margins evaluation by intraoperative ICG-FI during breast conserving surgery in patients treated for primary invasive BC, with an adequate negative predictive value.

Secondary objectives 3

1. To evaluate the clinical added value of intraoperative ICG-FI technique for surgical margins assessment during BCS after IV administration of ICG dye at a dose level
2. To assess the fluorescence of the primary breast tumor and to get more precision about the pathophysiological mechanism of action of ICG in BC tumors (by evaluation of ICG accumulation in intra or extracellular spaces and by the relation between tumoral vascularity and ICG fluorescence of BC tumors)
3. To investigate the fluorescence of the correspondent axillary lymph nodes (sentinel lymph node and /or lymph nodes of complete axillary dissection) by in-vivo and ex-vivo ICG-FI

Conditions and MedDRA coding

Patients with primary invasive early breast cancer (T1-T2) that will undergo planned breast-conserving surgery

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Female
2. Age of ≥18 years
3. Histological diagnosis of ductal invasive breast cancer
4. A primary early-stage invasive breast cancer (cT1 and/or cT2, assessed clinically and/or radiologically), without prior BC surgery of the actually affected breast
5. ECOG Performance Status (PS) 0 or 1
6. Signed informed consent form (ICF) obtained prior to any study related procedure

Exclusion criteria 14

1. Advanced invasive breast cancer cT3 and/or cT4
2. In situ breast cancer disease
3. Lobular invasive breast cancer at histology
4. Invasive breast cancer treated by neoadjuvant chemotherapy and/or endocrine therapy
5. Prior history of invasive or breast cancer of the actually affected breast in the past
6. History of allergy or hypersensitivity to investigational product (active substance or ingredients)
7. History of allergy to iodine or to shellfish
8. Have apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal, or disseminated autonomy of the thyroid gland
9. Documented coronary disease
10. Advanced renal insufficiency (serum creatinine >1.5 mg/dL)
11. Chronic liver disease with the Child-Pugh class B or C
12. Concurrent medication which reduces or increases the elimination of indocyanine green dye (ie, anticonvulsants, haloperidol, and heparin) during the 2 weeks before the expected operation
13. Pregnant or lactating women
14. Inability to give informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Accuracy of ICG-FI technique for the detection of positive (involved) surgical margins

Secondary endpoints 3

1. Comparison of ICG-FI technique accuracy at different doses and timing
2. Characterization of the breast tumor fluorescence (tumor-to-background fluorescence ratio)
3. Evaluation of fluorescence intensity of axillary lymph nodes

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Jules Bordet

Sponsor organisation

Institut Jules Bordet

Address

Mijlenmeersstraat 90

City

Brussels

Postcode

1070

Country

Belgium

Scientific contact point

Organisation

Institut Jules Bordet

Contact name

Clinical Trial Support Unit

Public contact point

Organisation

Institut Jules Bordet

Contact name

Clinical Trial Support Unit

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications