This pilot study hypothesizes that folate-FITC enhanced fluorescence imaging enables the intra-operative detection of breast carcinoma in breast cancer patients.
Bron
Verkorte titel
Aandoening
Breast cancer.
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
The main endpoint of this feasibility study is the intra-operative detection rate of breast carcinoma by a folate-FITC enhanced optical imaging device.
Achtergrond van het onderzoek
Rationale: 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.
Doel van het onderzoek
This pilot study hypothesizes that folate-FITC enhanced fluorescence imaging enables the intra-operative detection of breast carcinoma in breast cancer patients.
Onderzoeksopzet
Day of surgery.
Onderzoeksproduct en/of interventie
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.
Publiek
Department of Surgery / BioOptical Imaging Center Groningen <br>
G.M. Dam, van
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3612283
g.m.van.dam@chir.umcg.nl
Wetenschappelijk
Department of Surgery / BioOptical Imaging Center Groningen <br>
G.M. Dam, van
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3612283
g.m.van.dam@chir.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1963 |
NTR-old | NTR2081 |
Ander register | UMCG : BICG27 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Samenvatting resultaten
2. Sega EI, Low PS. Tumor detection using folate receptor-targeted imaging agents.
Cancer Metastasis Rev 2008; 27:655-664.