Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer
Phase II Study of Comparison of Sentinel Lymph Node Biopsy Guided by The Multimodal Method of Indocyanine Green Fluorescence, Radioisotope and Blue Dye Versus the Radioisotope in Breast Cancer
Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.
In this study, our hypotheses are as following:
- Multimodal method enables to increase identification rate of SLNB
- blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome
- Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Indocyanine green Advantages: provides visualization of sentinel lymph node without incision
Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes
Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republikken, 410-769
- National Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- clinically lymph node negative breast cancer patients
- consented patients with more than 20 years
Exclusion Criteria:
- history of breast cancer
- locally advanced breast cancer and metastatic breast cancer
- proven axillary lymph node metastasis
- history of axillary excisional or incisional biopsy, or dissection
- history of neoadjuvant chemotherapy
- pregnancy
- non-consented patients
- younger than 20 years old
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: radioisotope
sentinel lymph node operation using radioisotope in the breast cancer patients
|
Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation
|
|
Eksperimentell: the mixture including indocyanine green
sentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients
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Sentinel lymph node biopsy using near-infrared imaging system and gamma probe detector for the mixture of indocyanine green, blue dye, and radioisotope during operation
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to sentinel lymph node biopsy
Tidsramme: up to 6 months
|
From the date of randomization, skin necrosis and dye staining are assessed up to 6 months after the operation (post op 3 mon and 6 mon follow-up).
|
up to 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Identification rate of sentinel lymph node biopsy
Tidsramme: 13 months
|
The number of participants with sentinel lymph node detection is assessed up to 13 months.
|
13 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCC-1110212-2
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