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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.


- candidate number0
- NTR NumberNTR93
- ISRCTNISRCTN89530459
- Date ISRCTN created12-sep-2005
- date ISRCTN requested18-aug-2005
- Date Registered NTR21-jan-2005
- Secondary IDsZON-MW 945-04-311 2004/036 (projectnummer VUmc) 
- Public TitleFDG-PET for avoidance of futile direct laryngoscopies under general anaesthesia with taking of biopsies in patients with suspicion on recurrent laryngeal carcinoma after radiotherapy.
- Scientific TitleFDG-PET for avoidance of futile direct laryngoscopies under general anaesthesia with taking of biopsies in patients with suspicion on recurrent laryngeal carcinoma after radiotherapy.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedLaryngeal cancer , Carcinoma, Cancer, Tumour, Radiotherapy
- Inclusion criteria1. 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 criteria1. Age < 18 year;
2. Pregnancy;
3. Radiotherapy within the last 4 months.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-feb-2005
- planned closingdate1-feb-2009
- Target number of participants150
- InterventionsSelection 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: only direct laryngoscopy under general anaesthesia with taking of biopsies if FDG-PET is positive or equivocal.
- Primary outcomeNumber of direct laryngoscopies (on a group level) needed to detect (a single) recurrent laryngeal carcinoma.
- Secondary outcomeKey: 1. Costs;
2. Operability of a recurrence;
3. Surgical margins of the salvage laryngectomy;
4.Quality of life.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. R. Bree, de
- CONTACT for SCIENTIFIC QUERIESDrs. L. Putten, van der
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD17-aug-2005 - 18-dec-2006


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