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

Detection of Breast Carcinoma with an ICG Enhanced Optical Imaging Device in Breast Cancer Patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22989
Enrollment
10
Registered
2009-10-28
Start date
2009-01-10
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer.

Interventions

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 convent

Sponsors

University Medical Center Groningen (UMCG), Department of Surgery.
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The primary outcome of this pilot study is the feasibility of intra-operative detection of breast carcinoma with an ICG enhanced optical imaging device.

Contacts

Public ContactG.M. Dam, van

University Medical Center Groningen Department of Surgery / BioOptical Imaging Center Groningen

g.m.van.dam@chir.umcg.nl+31 (0)50 3612283

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)