- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01609920
Nodal Staging in Breast Cancer With MRL
Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset
The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL).
The diagnostic performance of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the golden standard for nodal involvement.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Limburg
-
Maastricht, Limburg, Holland, 6225 HX
- Maastricht University Medical Center (MUMC) AZM
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Female patient with histopathologically confirmed breast cancer about to undergo nodal staging.
- Willing and able to undergo all study procedures
- Has personally provided written informed consent.
Exclusion Criteria:
- Age <18,
- Pregnancy
- Contra indications for MRL such as pacemaker, aneurysm clips or severe claustrophobia.
- Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)
- Being unable to give informed consent in person
- Acute or chronic severe renal insufficiency (glomerular filtration rate <45 mL/min/1.73m2)1.
- Acute renal insufficiency of any severity due to the hepato-renal syndrome.
- Known (or suspicion of) QT- prolongation
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 |
---|---|
Eksperimentel: Gadofosveset MRL
|
A MRL of the axilla will be performed before and after administration of a single IV bolus injection of gadofosveset of an equivalent of 0.03 mmol Gd/kg body weight at an injection speed of 1.5 mL/sec., followed by a saline flush of 25 mL at an injection speed of 1.5 mL/sec.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL in predicting the involvement of metastases
Tidsramme: Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks.
|
The main study parameter will be the diagnostic performace (sensitivity, specificity, NPV and PPV) of the axillary MRL in predicting the involvement of metastases in the investigated lymph nodes.
Each node will be scored on MRL as 0= benign, 1=malign.
These results will be compared with the histopathological results of the SNLB procedure of ALND procedure on an node by node basis.
So the diagnostic performace can be calculated.
|
Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks.
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: R.G.H. Beets-Tan, MD, PhD, Maastricht University Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12-2-032
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