Intra-operative imaging of lymph node metastases in cervical cancer.

Evaluation of a clinical prototype near-infrared fluorescence (NIRF) imaging device for detection of lymph node (LN) metastases in cervical cancer: a technical feasibility study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27596

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

Cervical cancer baarmoederhalskanker

Interventions

Patients with cervical cancer undergoing surgery (radical hysterectomy with bilateral pelvic lymphadenectomy), will receive a peritumoural injection with Indocyanine Green (ICG) and patent blue after

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female > 21 years of age; 2. Operable cervical cancer stage IAI, IBI or IIA.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Identification of sentinel lymph nodes within the allocated procedure (usually 30 minutes) by detection of fluorescence.	—

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)