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Multicenter studie naar de klinische relevantie van één injectie per tumor voor de schildwachtklierprocedure bij patiënten met multiple borsttumoren


- candidate number19292
- NTR NumberNTR4737
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-aug-2014
- Secondary IDsM13MUL MULTISENT-II
- Public TitleMulticenter studie naar de klinische relevantie van één injectie per tumor voor de schildwachtklierprocedure bij patiënten met multiple borsttumoren
- Scientific TitleMulticenter study on the clinical relevance of one injection per tumor for sentinel node biopsy in patients with multiple breast tumors
- ACRONYMMULTISENT-II
- hypothesisAIM: Establish the clinical value of sentinel node biopsy in patients with multiple breast tumors. Investigate if an intratumoral tracer injection in the additional tumors results in visualization of extra sentinel nodes/extra lymphatic drainage basins in comparison to an intratumoral injection in the largest tumor (standard).
HYPOTHESIS: There is a difference in lymphatic drainage pattern (and thereby the number /location of the sentinel node(s)) between the largest tumor and the additional tumors.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Sentinel node biopsy, Sentinel lymph node localization
- Inclusion criteria1. Patients presenting at one of the participating centers with two or three invasive tumors in one or more quadrants of the breast
2. The minimal distance between two different invasive foci must be two centimeters
3. The minimal diameter of an invasive focus (of one tumor) must be one centimeter
4. Patients are clinically staged with negative lymph nodes in the axilla.
- Exclusion criteria1. The maximum diameter of the tumor larger than five centimeters
2. Evidence of other breast-cancer related disease such as palpable or ultrasound detected lymph node metastases or distant metastases.
3. Exclusive presence of ductal carcinoma in situ (DCIS).
4. Incapacity or unwillingness of participant to give written informed consent
5. Patients with known allergy to patent blue;
6. Patients who are pregnant or nursing mothers
7. History of hypersensitivity reactions to products containing human serum albumin
8. History of iodine allergy
9. Hyperthyroid or thyroidal adenoma
10. Kidney insufficiency
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytype[default]
- planned startdate 1-jul-2014
- planned closingdate1-jul-2016
- Target number of participants58
- InterventionsPatients who are scheduled for a sentinel node procedure will receive two injections with radioactive labelled nanocolloid. In the (most) medial tumor ICG-99mTc-nanocolloid will be administered, in the lateral tumor(s) the standard 99mTc-nanocolloid is injected. After both injections the normal procedure will be followed.
- Primary outcomeThe aim of the study is to determine the clinical value of the sentinel node procedure in breast cancer patients with multiple tumors and to investigative whether an intratumoral injection of the radiopharmaceutical in each tumor will lead to identification of additional sentinel nodes and/or extra lymphatic drainage locations compared to an intratumoral injection of the radiopharmaceutical in the largest tumor only.
- Secondary outcome-
- Timepoints-
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES H.S.A. Oldenburg
- CONTACT for SCIENTIFIC QUERIES H.S.A. Oldenburg
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL) , Rijnland Hospital
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL), Rijnland Hospital Leiderdorp
- PublicationsBrouwer et al., EJNMMI 2012
- Brief summaryLymphoscintigraphy in breast cancer patients can determine the lymphatic drainage pattern and the location of the first draining lymph nodes, the sentinel nodes. Sentinel nodes are likely to be the first nodes to harbor tumor cells, which may alter the patients’ management. The purpose of this study is to further establish the clinical value of lymphoscintigraphy and sentinel node biopsy in patients with multiple invasive tumors in one ore more quadrants of the breast. In a first evaluation of the M08ML study including 50 patients receiving separate tumor 99m Tc-nanocolloid injections a 64% additional lymphatic drainage was found after tracer administration in the smaller tumors of the breast.1 In only 5 patients the additionally detected sentinel nodes contained tumor; however, in these patients also the sentinel nodes draining from the largest tumor contained metastases. In two other patients isolated tumor cells were found only in the additional sentinel nodes. Based on the findings of this first evaluation, and following the recommendations of the reviewers of the manuscript, the investigators consider a follow-up to the study as necessary. In this modified follow-up study an additional number of patients will be evaluated in order to demonstrate, or exclude, the clinical relevance of the additional sentinel nodes. In order to simplify the protocol all tumors in the breast will be injected at the same time.
- Main changes (audit trail)
- RECORD12-aug-2014 - 3-sep-2014


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