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Detectie van het mammacarcinoom met behulp van een innovatief beeldvormingssysteem en folaat-FITC bij patiŽnten met borstkanker.


- candidate number6671
- NTR NumberNTR2081
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2009
- Secondary IDsBICG27 UMCG
- Public TitleDetectie van het mammacarcinoom met behulp van een innovatief beeldvormingssysteem en folaat-FITC bij patiŽnten met borstkanker.
- Scientific TitleDetection of Breast Cancer using Folate-FITC Enhanced Optical Imaging in Breast Cancer Patients.
- ACRONYMNIRF tumor detection.
- hypothesisThis pilot study hypothesizes that folate-FITC enhanced fluorescence imaging enables the intra-operative detection of breast carcinoma in breast cancer patients.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteriaWomen 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 (°›2+), as determined by immunohistochemistry prior to surgery.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-nov-2009
- planned closingdate1-feb-2010
- Target number of participants10
- InterventionsFour (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.
- Primary outcomeThe main endpoint of this feasibility study is the intra-operative detection rate of breast carcinoma by a folate-FITC enhanced optical imaging device.
- Secondary outcomeN/A
- TimepointsDay of surgery.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. G.M. Dam, van
- CONTACT for SCIENTIFIC QUERIESDr. G.M. Dam, van
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications1. Hartmann LC, Keeney GL, Lingle WL et al. Folate receptor overexpression is associated with poor outcome in breast cancer. Int J Cancer 2007; 121:938-942.
2. Sega EI, Low PS. Tumor detection using folate receptor-targeted imaging agents. Cancer Metastasis Rev 2008; 27:655-664.
- Brief summaryRationale: In this pilot, the feasibility of the promising optical contrast agent folate-FITC (EC17) is being investigated. Folate-FITC is targeted specifically towards folate receptors (FR), which are up-regulated in a variety of human cancers, including breast cancer. This over-expression of FR in tumour cells can be exploited to differentiate between malignant and healthy tissue, the latter expressing few if any FR. After intravenous injection of folate-FITC, FR-positive tumour cells may be detected and visualized with an optical imaging system, thereby offering the surgeon real-time intra-operative information on tumour location and margin status without changing the surgical procedure itself nor the design of the operating theatre. It is expected that optical imaging will enable the surgeon to detect (diagnostic) and at the same time excise (therapeutic) malignant tissue and any residual disease during breast-conserving surgery, thereby decreasing the number of re-excisions needed after BCT and eventually costs.
- Main changes (audit trail)
- RECORD28-okt-2009 - 5-nov-2009


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