Detection of recurrent head and neck squamous cell carcinomas with DW-MRI after (chemo)radiatio

Completed

Conditions: hypopharyngeal and oropharyngeal carcinoma
laryngeal
oral and throat cancer
10027655

Registration Number: NL-OMON35371

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 74

Inclusion Criteria

Patients with clinical suspicion of local recurrence after treated for laryngeal- hypopharyngeal- or oropharyngeal squamous cell carcinoma with (chemo)radiation.
Primary (chemo)radiation for the primary tumour region
Last radiotherapy: > 2 months and < 3 years
*Informed consent* signed by patient
Age * 18 years

Exclusion Criteria

Patient with contraindication of MRI or contrast agent as defined in the protocols of the radiology department of the UMCU
Patients with primary salvage surgery for the primary lesion
Patients whom recurrence is obvious that no additional imaging confirmation is necessary for the decision to take biopsies.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The outcome of the study is the presence or absence of histological validated<br /><br>recurrent HNSCC within 6 months after the suspicion. The diagnostic performance<br /><br>of DW-MRI for the detection of recurrence in patients with clinical suspicion<br /><br>of recurrent or persistent HNSCC after initial (chemo)radiation as reflected by<br /><br>the positive predictive value, negative predictive value, sensitivity and<br /><br>specificity of DW-MRI. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the number of futile biopsy procedures if DW-MRI would<br /><br>be used as selection strategy and the extra yield by DW-MRI; the number of<br /><br>patients with a histological proven recurrence whereby DW-MRI was positive and<br /><br>regular imaging was negative. In addition the missed recurrences with DW-MRI;<br /><br>the number of patients with histological recurrence within 6 months whereby the<br /><br>DW-MRI was negative.</p><br>