| - candidate number | 0 |
| - NTR Number | NTR93 |
| - ISRCTN | ISRCTN89530459 |
| - Date ISRCTN created | 12-sep-2005 |
| - date ISRCTN requested | 18-aug-2005 |
| - Date Registered NTR | 21-jan-2005 |
| - Secondary IDs | ZON-MW 945-04-311 2004/036 (projectnummer VUmc) |
| - Public Title | 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. |
| - Scientific Title | 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. |
| - ACRONYM | N/A |
| - hypothesis | N/A |
| - Healt Condition(s) or Problem(s) studied | Laryngeal cancer , Carcinoma, Cancer, Tumour, Radiotherapy |
| - 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 | 1. Age < 18 year; 2. Pregnancy; 3. Radiotherapy within the last 4 months. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-feb-2005 |
| - planned closingdate | 1-feb-2009 |
| - Target number of participants | 150 |
| - 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: only direct laryngoscopy under general anaesthesia with taking of biopsies if FDG-PET is positive or equivocal. |
| - Primary outcome | Number of direct laryngoscopies (on a group level) needed to detect (a single) recurrent laryngeal carcinoma. |
| - Secondary outcome | Key:
1. Costs; 2. Operability of a recurrence; 3. Surgical margins of the salvage laryngectomy; 4.Quality of life. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Dr. R. Bree, de |
| - CONTACT for SCIENTIFIC QUERIES | Drs. 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 |
| - Publications | N/A |
| - Brief summary | N/A |
| - Main changes (audit trail) | |
| - RECORD | 17-aug-2005 - 18-dec-2006 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl
- Dit zijn de gegevens waarmee uw trial is aangemeld en geregistreerd in het Nederlands Trial Register