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Validation of diffusion weighted MR images of laryngeal cancer with histopathology

Validation of diffusion weighted MR images of laryngeal cancer with histopathology - CORRECT II

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55866
Enrollment
20
Registered
2016-03-15
Start date
2016-09-30
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

laryngeal cancer Laryngeal carcinoma

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with a T3 or T4 laryngeal or hypopharyngeal cancer scheduled for total laryngectomy. - Age >= 18 years. - Informed consent.

Exclusion criteria

Exclusion criteria: - Patients with indications for primary radiotherapy. - Patients with contraindications for surgery. - Patients who meet exclusion criteria for MRI at 3T as defined in the protocols of the Radiology department. - Patients with contraindication for CT contrast administration as defined in the protocols of the Radiology department. - Patients with insulin dependent diabetes mellitus.

Design outcomes

Primary

MeasureTime frame
The accuracy of DW-MRI in determining the volume of the tumour.

Secondary

MeasureTime frame
The sensitivity (part of the tumour that is delineated) and positive predictive power (part of the delineated volume that is tumour) of DW-MRI based tumour delineation compared with values obtained using CT, PET and anatomical MR imaging. The microscopic extension of the tumour measured as the distance between the gross tumour volume and the most distant microscopic lesions in the histopathology.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)