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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33445
Enrollment
10
Registered
2009-06-23
Start date
2019-07-23
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Esophageal cancer Gullet cancer

Interventions

Patients with operable esophageal cancer undergoing esophagectomy with two-field-lymphadenectomy, either by a left- or right-sided abdomino-thoracotomy, will receive pre-operatively an intratumoral

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Resectable esophageal carcinoma > 21 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Ergonomics and function of the NIRF imaging system - the NIRF imaging system must not interfere with the standard esophagectomy and lymphadenectomy procedure and should be used safely by the surgeon. Duration of data acquisition: ~30 minutes.

Secondary

MeasureTime frame
Identify draining lymph nodes within the allocated procedure (usually 4-6 hours)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)