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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR3172 |
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Date of registration:
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02/12/2011 |
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Primary sponsor: |
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Public title:
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Detection of recurrent head and neck tumours after chemoradiation with a tumor-sensitive MRI technique.
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Scientific title:
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Detection of recurrent head and neck squamous cell carcinomas with Diffusion Weighted MRI after (chemo)radiation.
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Date of first enrolment:
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1/12/2011 |
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Target sample size:
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75 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3172 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: Parallel; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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W.
Grolman |
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Address:
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, Dept. of Otolaryngology
Room G05.129
Heidelberglaan 100
3584 CX
Utrecht
The Netherlands |
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Telephone:
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+31 (0)88 75 566 44 |
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Email:
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W.Grolman@umcutrecht.nl |
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Affiliation:
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Name:
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W.
Grolman |
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Address:
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, Dept. of Otolaryngology
Room G05.129
Heidelberglaan 100
3584 CX
Utrecht
The Netherlands |
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Telephone:
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+31 (0)88 75 566 44 |
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Email:
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W.Grolman@umcutrecht.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with a oropharyngeal, hypopharyngeal, or laryngeal squamous cell carcinoma treated with (chemo)radiation with curative intent;
2. A clinical suspicion of a recurrence;
3. Last radiotherapy: > 2 months and < 3 years ago;
4. ?Informed consent? signed by patient;
5. Age ≥ 18 years.
Exclusion criteria: 1. Patients with contraindication for MRI or contrast agent;
2. Patients who received salvage surgery for the primary lesion;
3. Patients whom recurrence is so obvious that no additional imaging confirmation is necessary for the decision to take biopsies.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Radiotherapy, Squamous cell carcinoma (SCC), Recurrent
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Intervention(s)
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One additional Diffusion Weighted MRI added to the regular imaging of choice.
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Primary Outcome(s)
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The diagnostic performance of DW-MRI for the detection of recurrence in patients with clinical suspicion of recurrent or persistent HNSCC after initial (chemo) radiation will be primarily reflected by the PPV of DW-MRI. Furthermore, the NPV, discrimination, sensitivity and specificity will be assessed.
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Secondary Outcome(s)
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1. Number of futile biopsies with DW-MRI as selection strategy for endoscopy with taking of biopsies;
2. Discordant pairs (Regular imaging vs. DW-MRI);
3. Number of missed cases by DW-MRI compared to regular imaging;
4. Number of extra cases detected by DW-MRI compared to regular imaging.
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Secondary ID(s)
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NL37889.041.11
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Source(s) of Monetary Support
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University Medical Center Utrecht (UMCU)
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