Detection of residual tumor tissue during surgery in ovarian cancer.

Detection of residual disease using Folate-FITC enhanced optical imaging in ovarian carcinoma.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24387

Enrollment

Registered

2009-08-31

Start date

2009-07-01

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

ovarian cancer eierstokkanker ovariumkanker

Interventions

Administration of folate-FITC prior to surgery. During surgery, a near-infrared fluorescence intra-operative camera system will be used to detect residual tumor tissue.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female > 21 years old; 2. Ovarian cancer for which debulking surgery is scheduled.

Exclusion criteria

Exclusion criteria: 1. Renal, cardiac or pulmonary failure (ASA III-IV); 2. Present or previous hyperthyreoidism; 3. Iodine allergy or previous anaphylactic reactions; 4. Pregnancy.

Design outcomes

Primary

Measure	Time frame
Intra-operative detection of ovarian cancer by a folate-FITC enhanced optical imaging device, in which visual inspection in combination with routine histology is considered the golden standard for the presence of tumour tissue.	—

Secondary

Measure	Time frame
Presence of fluorescent residual disease after intended radical resection by visual observation alone.	—

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)