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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35371

Enrollment

Registered

2011-11-17

Start date

2011-12-05

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypopharyngeal and oropharyngeal carcinoma laryngeal oral and throat cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The outcome of the study is the presence or absence of histological validated recurrent HNSCC within 6 months after the suspicion. 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 as reflected by the positive predictive value, negative predictive value, sensitivity and specificity of DW-MRI.	—

Measure

Time frame

The outcome of the study is the presence or absence of histological validated recurrent HNSCC within 6 months after the suspicion. 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 as reflected by the positive predictive value, negative predictive value, sensitivity and specificity of DW-MRI.

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Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results