Evaluation of a Clinical Prototype Near-InfraRed Fluorescence (NIRF) Imaging Device for Lymph Node Mapping in Esophageal Cancer: a Technical Feasibility Study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27000

Enrollment

Registered

2009-09-10

Start date

2009-06-23

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

Esophageal cancer

Interventions

Peritumoral injection with indocyanine green and subsequent imaging using the intraoperative near-infrared fluorescence camera.

Eligibility

Inclusion criteria

Inclusion criteria: Men and women above the age of 21 who have biopsy-proven esophageal cancer that is deemed operable by the treating surgeon by the current staging protocol at the UMCG (i.e. endoscopy, endo ultrasound, CT thorax/abdomen, PET scan).

Exclusion criteria

Exclusion criteria: 1. Significant renal, cardiac, or pulmonary disease (ASA III-IV); 2. History of iodine allergy or anaphylactic reactions to insect bites or medication; 3. Presence or history of hyperthyroidism.

Design outcomes

Primary

Measure	Time frame
Application of the near-infrared fluorescence camera safely without disturbing the normal operative procedure.	—

Secondary

Measure	Time frame
Detection of lymph nodes with the near-infrared fluorescence camera.	—

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)