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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2081 |
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Date of registration:
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28/10/2009 |
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Primary sponsor: |
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Public title:
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Detectie van het mammacarcinoom met behulp van een innovatief beeldvormingssysteem en folaat-FITC bij patiënten met borstkanker.
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Scientific title:
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Detection of Breast Cancer using Folate-FITC Enhanced Optical Imaging in Breast Cancer Patients. - NIRF tumor detection. |
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Date of first enrolment:
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1/11/2009 |
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Target sample size:
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10 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2081 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: [default]; Control: [default]; Group: Parallel; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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G.M.
Dam, van |
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Address:
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University Medical Center Groningen
Department of Surgery / BioOptical Imaging Center Groningen
, Hanzeplein 1
9700 RB
Groningen
The Netherlands |
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Telephone:
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+31 (0)50 3612283 |
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Email:
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g.m.van.dam@chir.umcg.nl |
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Affiliation:
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Name:
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G.M.
Dam, van |
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Address:
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University Medical Center Groningen
Department of Surgery / BioOptical Imaging Center Groningen
, Hanzeplein 1
9700 RB
Groningen
The Netherlands |
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Telephone:
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+31 (0)50 3612283 |
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Email:
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g.m.van.dam@chir.umcg.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Women above the age of 21 who have biopsy-proven stage I-II breast cancer and who are planning to undergo lumpectomy as a treatment for their disease. Furthermore, folate receptor (FR) expression of the tumour must be strong (¡Ý2+), as determined by immunohistochemistry prior to surgery.
Exclusion criteria: 1. Refusal of the patient to be included in the study;
2. Pregnant or breast-feeding;
3. Significant renal dysfunction (serum creatinin above 400 micromol/L);
4. Cardiac and/or pulmonary disease (ASA III-IV);
5. History of fluorescein allergy or anaphylactic reactions to insect bites or medication.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Breast cancer
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Intervention(s)
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Four (4) hours prior to the surgical procedure, the patient receives an injection with 0,3 mg/kg bodyweight folate-FITC compound in the cephalic vein through an intravenous infusion. The standard lumpectomy procedure is followed as normal. During the actual lumpectomy, the presence of tumour-bound folate-FITC is assessed by placing the optical imaging camera approximately 20 cm above the region of interest (operative field). This imaging procedure is additional to a standard lumpectomy and may result in a prolonged operation time up to 15-30 minutes.
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Primary Outcome(s)
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The main endpoint of this feasibility study is the intra-operative detection rate of breast carcinoma by a folate-FITC enhanced optical imaging device.
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Source(s) of Monetary Support
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University Medical Center Groningen (UMCG)
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