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Evaluatie van een nieuwe optische beeldvormingstechniek voor de detectie van het mammacarcinoom bij patiŽnten met borstkanker.


- candidate number6672
- NTR NumberNTR2082
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2009
- Secondary IDsBICG02 UMCG-NIRF
- Public TitleEvaluatie van een nieuwe optische beeldvormingstechniek voor de detectie van het mammacarcinoom bij patiŽnten met borstkanker.
- Scientific TitleDetection of Breast Carcinoma with an ICG Enhanced Optical Imaging Device in Breast Cancer Patients.
- ACRONYMNIRF-guided tumour detection.
- hypothesisThis pilot study hypothesizes that ICG enhanced near-infrared fluorescence (NIRF) optical 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 18 who have biopsy-proven stage I-II breast cancer and who are planning to undergo lumpectomy as a treatment for their disease.
- Exclusion criteria1. Refusal of the patient to be included in the study;
2. Pregnant or breast-feeding;
3. Significant renal dysfunction (serum creatinine above 400 micromol/L);
4. Significant cardiac and/or pulmonary disease (ASA III-IV);
5. History of iodine allergy or anaphylactic reactions to insect bites or medication;
6. Presence or history of hyperthyroidism;
7. Recent surgery on the breast.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 10-jan-2009
- planned closingdate2-jan-2010
- Target number of participants10
- InterventionsAt the start of the surgery and during anesthesia, the patient receives an intravenous injection with ICG compound in the cephalic vein. The lumpectomy procedure is followed in accordance with conventional guidelines. During the actual lumpectomy, the presence of ICG leakage in the tumour vasculature is assessed by holding a near-infrared fluorescence optical imaging device directly above (~20 cm) the region of interest (operative field).
- Primary outcomeThe primary outcome of this pilot study is the feasibility of intra-operative detection of breast carcinoma with an ICG 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)
- PublicationsSevick-Muraca EM, Sharma R, Rasmussen JC, Marshall MV, Wendt JA, Pham HQ, Bonefas E, Houston JP, Sampath L, Adams KE, Blachard DK, Fischer RE, Chiang SB, Elledge R, Mawad ME. Imaging of lymph flow in breast cancer patients after microdose administration of a near-infrared fluophore: Feasibility study. Radiology 2008; 246: 734-741.
- Brief summaryRationale: ICG is a blood pool agent which is expected to delineate tumours by the fact that there are leaky vessels originating from angiogenesis from which the compound leaks into the tumour and surrounding tissue. After intravenous injection of ICG, tumour cells may be detected and visualized with a near-infrared fluorescence (NIRF) optical imaging system, thereby offering the surgeon real-time intra-operative information on tumour location and margin status without changing the surgical procedure itself. 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. This pilot study is designed to determine the feasibility of a novel optical imaging device enhanced with ICG for the intra-operative detection of breast carcinoma. Subsequently, this might provide a platform technique for patient tailored surgical interventions and tumour-specific contrast agents in the future.
- Main changes (audit trail)
- RECORD28-okt-2009 - 5-nov-2009


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