No registrations found.
ID
Source
Brief title
Health condition
Breast cancer.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this pilot study is the feasibility of intra-operative detection of breast carcinoma with an ICG enhanced optical imaging device.
Secondary outcome
N/A
Background summary
Rationale: 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.
Study objective
This pilot study hypothesizes that ICG enhanced near-infrared fluorescence (NIRF) optical imaging enables the intra-operative detection of breast carcinoma in breast cancer patients.
Study design
Day of surgery.
Intervention
At 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).
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
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
Inclusion criteria
Women 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL1965 |
NTR-old | NTR2082 |
Other | UMCG-NIRF : BICG02 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |