FDG-PET for avoidance of futile direct laryngoscopies under general anaesthesia with taking of biopsies in patients with suspicion on recurrent laryngeal carcinoma after radiotherapy.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23769

Enrollment

150

Registered

2005-01-21

Start date

2005-02-01

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

None listed

Interventions

Selection for direct laryngoscopy with FDG-PET. Two strategy arms are compared: 1. Conventional strategy: direct laryngoscopy under general anaesthesia with taking of biopsies 2. PET based strategy:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with clinical suspicion on recurrent laryngeal carcinoma after radiotherapy (without obvious signs of tumour), in whom a direct laryngoscopy under general anaesthesia with taking of biopsies is indicated; 2. T2-T4 laryngeal carcinoma.

Exclusion criteria

Exclusion criteria: 1. Age < 18 year; 2. Pregnancy; 3. Radiotherapy within the last 4 months.

Design outcomes

Primary

Measure	Time frame
Number of direct laryngoscopies (on a group level) needed to detect (a single) recurrent laryngeal carcinoma.	—

Secondary

Measure	Time frame
Key: 1. Costs; 2. Operability of a recurrence; 3. Surgical margins of the salvage laryngectomy; 4.Quality of life.	—

Contacts

Public ContactR. Bree, de

VU University Medical Center, Department of Otolaryngology /Head and Neck Surgery, Boelelaan 1117

r.bree@vumc.nl+31 (0)20 4443690

Outcome results