Study of the ICG Distribution in Breast Tumours or in Axillary Lymph Nodes of Patients After Neoadjuvant Therapy
Study of the (Intravenously Injected) Indocyanine Green Distribution in Tumour Bearing Breasts and in Axillary Pieces of Dissection of Patients Who Have Received Neoadjuvant Therapy for Histologically Proven Mammary Cancer
Studieoversigt
Detaljeret beskrivelse
In the operating room:
ICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation.
Optionally, dynamic NIR imaging centered on the tumor bearing breast will be acquired during the 15 minutes after injection (in comparison with standards of known fluorescence intensity).
Optionally and in case of tumorectomy, peroperative "in vivo" imaging of the surgical dissection will be acquired. The tumour and/or the mammary piece (and the axillary piece) of dissection will be directly imaged "ex vivo" using the PDE camera (in comparison with standards of known fluorescence intensity).
In the Laboratory of Pathology:
The fresh mammary piece will be processed as usual, but the "gross-thick" sections will be imaged using the PDE and the fluorescent areas will be defined (and later analyzed in comparison with standards of known fluorescence intensity).
After fixation, the tumoral tissues as well as - if identified - non tumoral fluorescent foci will be thereafter processed "as usual".
All the slides obtained will be analyzed using the NIR fluorescent microscope for the presence or not of detectable ICG and the ICG-positive tissues or compartments (vascular spaces, interstitial spaces, normal and/or tumoral cells, macrophages…) will be determined.
If fluorescent foci are identified at the level of the axillary piece, they will be isolated and analyzed like the other lymph nodes. Using the NIR fluorescent microscope, these isolated macroscopically fluorescent structures will be analyzed (lymph node? Other?).
Additionally, metastatic lymph nodes will also be controlled for their microscopic fluorescence or not.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Brussels, Belgien, 1000
- Rekruttering
- Jules Bordet Institute
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Kontakt:
- Pierre Bourgeois, MD
- Telefonnummer: 003225413276
- E-mail: pierre.bourgeois@bordet.be
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Ledende efterforsker:
- Isabelle Veys, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with histopathological diagnosis of mammary cancer who have received neoadjuvant therapy and are candidate, either for tumorectomy, or for mastectomy with complete axillary node dissection,
- Informed consent form signed.
Exclusion Criteria:
- Diagnosis of mammary cancer established, either by tumorectomy, or 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Indocyanine Green
intravenous injection of 0.25mg/kg Indocyanine Green just before surgery
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intravenous injection of 0.25mg/kg Indocyanine Green just before the surgery
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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fluorescence intensity of tumoral lesions, scars and healthy tissues after IV injection of ICG in breast cancer patients after neoadjuvant therapy
Tidsramme: 1 week
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1 week
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Isabelle Veys, MD, Surgeon in Jules Bordet Institute
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- BR-ICG-IV-NACT
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