Study to see if it is possible to guide tumorectomy in case of breast cancer by near-infrared fluorescence after intravenous injection of Indocyanine Green

Study evaluating breast cancer tumorectomy guided by Near-Infrared imaging after the intravenous injection of free Indocyanine Green

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003268-19-BE

Enrollment

Registered

2014-09-10

Start date

2014-10-06

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Imaging of tumours and their margins after intravenous injection of Indocyanine Green to breast cancer patients

Interventions

Trade Name: Indocyanine Green Pulsion 25 mg Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Indocyanine Green CAS Number: 3599-32-4 Current Sponsor code: BR-TUM-ICG-IV-2 Ot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with SLN selective lymphadenectomy, or with complete axillary node dissection. - Patients with tumorectomy foreseen after neo-adjuvant therapy will also be enrolled. - Informed consent form signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Diagnosis of mammary cancer established by “gross” biopsy. - Age less than18 years old. - Inability to give informed consent. - History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish. - Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland. - Documented coronary disease. - Advanced renal impairment (creatinine > 1,5mg/dl). - During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and heparin). - Pregnancy, breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation (on a preliminary series of 20 patients) of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to guide the surgeons during the surgery when they are performing tumorectomy of breast cancer. Evaluation of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to show fluorescent “remaining in site” tumoral tissues after such tumorectomy (and how frequently it will happen) and analysis of their histopathological characteristics. ;Secondary Objective: Comparison to “historical” matched cases of the results of so performed tumorectomies. The following parameters will be analysed: - Size of the tumorectomy pieces. - Distances between margins and tumoral limits. - Positivity of the margins. - Delayed interventions for positive margins. Analysis of the correlation between ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist Evaluation of the ability of NIR fluorescence imaging camera device (after the intravenous injection of free ICG) to show fluorescent the sentinel lymph nodes of these patients among the axillary tissues and during their research, resection and (ex vivo and in vivo) analysis of the fluorescence ratios between the SLN and their surrounding fatty tissues ;Primary end point(s): Evaluation (on a preliminary series of 20 patients) of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to guide the surgeons during the surgery when they are performing tumorectomy of breast cancer. Evaluation of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to show fluorescent “remaining in site” tumoral tissues after such tumorectomy (and how frequently it will happen) and analysis of their histopathological characteristics. ;Timepoint(s) of evaluation of this end point: After surgery and pathological analysis of the patient	—

Measure

Time frame

Main Objective: Evaluation (on a preliminary series of 20 patients) of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to guide the surgeons during the surgery when they are performing tumorectomy of breast cancer. Evaluation of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to show fluorescent “remaining in site” tumoral tissues after such tumorectomy (and how frequently it will happen) and analysis of their histopathological characteristics. ;Secondary Objective: Comparison to “historical” matched cases of the results of so performed tumorectomies. The following parameters will be analysed: - Size of the tumorectomy pieces. - Distances between margins and tumoral limits. - Positivity of the margins. - Delayed interventions for positive margins. Analysis of the correlation between ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist Evaluation of the ability of NIR fluorescence imaging camera device (after the intravenous injection of free ICG) to show fluorescent the sentinel lymph nodes of these patients among the axillary tissues and during their research, resection and (ex vivo and in vivo) analysis of the fluorescence ratios between the SLN and their surrounding fatty tissues ;Primary end point(s): Evaluation (on a preliminary series of 20 patients) of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to guide the surgeons during the surgery when they are performing tumorectomy of breast cancer. Evaluation of the ability of NIR fluorescence imaging (after the intravenous injection of free ICG) to show fluorescent “remaining in site” tumoral tissues after such tumorectomy (and how frequently it will happen) and analysis of their histopathological characteristics. ;Timepoint(s) of evaluation of this end point: After surgery and pathological analysis of the patient

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Secondary

Measure	Time frame
Secondary end point(s): Comparison to “historical” matched cases of the results of so performed tumorectomies. The following parameters will be analysed: - Size of the tumorectomy pieces. - Distances between margins and tumoral limits. - Positivity of the margins. - Delayed interventions for positive margins. Analysis of the correlation between ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist Evaluation of the ability of NIR fluorescence imaging camera device (after the intravenous injection of free ICG) to show fluorescent the sentinel lymph nodes of these patients among the axillary tissues and during their research, resection and (ex vivo and in vivo) analysis of the fluorescence ratios between the SLN and their surrounding fatty tissues Evaluation of one prototype of probe dedicated to the ICG fluorescence detection but also coupled to a gamma probe. This prototype will be evaluated as a complementary way to identify the radioactive sentinel lymph nodes in our patients ;Timepoint(s) of evaluation of this end point: After surgery and pathological analysis of the patient	—

Measure

Time frame

Secondary end point(s): Comparison to “historical” matched cases of the results of so performed tumorectomies. The following parameters will be analysed: - Size of the tumorectomy pieces. - Distances between margins and tumoral limits. - Positivity of the margins. - Delayed interventions for positive margins. Analysis of the correlation between ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist Evaluation of the ability of NIR fluorescence imaging camera device (after the intravenous injection of free ICG) to show fluorescent the sentinel lymph nodes of these patients among the axillary tissues and during their research, resection and (ex vivo and in vivo) analysis of the fluorescence ratios between the SLN and their surrounding fatty tissues Evaluation of one prototype of probe dedicated to the ICG fluorescence detection but also coupled to a gamma probe. This prototype will be evaluated as a complementary way to identify the radioactive sentinel lymph nodes in our patients ;Timepoint(s) of evaluation of this end point: After surgery and pathological analysis of the patient

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Countries

Belgium

Contacts

Public ContactProf. Pierre Bourgeois

Jules Bordet Institute

pierre.bourgeois@bordet.be003225413276

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026