Clinical value of (improved) 3 Tesla and 7 Tesla MR Imaging on depiction of T1 laryngeal carcinoma

Clinical value of (improved) 3 Tesla and 7 Tesla MR Imaging on depiction of T1 laryngeal carcinoma - 3T and 7T larynx study/LOCATE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42195

Enrollment

Registered

2014-11-03

Start date

2014-12-17

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

cancer of the vocal cord laryngeal carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with primary clinical Tis, T1a and T1b glottic carcinoma, scheduled for treatment with CO2 laser therapy or radiotherapy - Capablility of written informed consent - Written informed consent

Exclusion criteria

Exclusion criteria: - Patients with a history of previous glottic surgery - Patients with recurrence of glottic disease - Legal incapability - Insufficient command of the Dutch language - Patients with body implants, not compatible with MRI - Patients with Claustrofobia - Pregnant patients - Creatinine clearance of

Design outcomes

Primary

Measure	Time frame
To assess the feasibility of the clinical use of 3T MR imaging of early laryngeal carcinoma; - Systematic assessment of technical image quality and assessment of tumour visibility on 3T MRI. - Anteroposterior tumour extension, lateral tumour extension (measured from free edge of the vocal fold in mm), estimated tumour infiltration depth (mm) and estimated tumour volume (cc) after delineation of the tumour at 3T MRI by an experienced head and neck radiologist. - Anteroposterior tumour extension and lateral tumour extension (measured from free edge of the vocal fold in mm) during direct suspension laryngoscopy (reference standard). - Tumour infiltration depth (in mm and invasion of tissue layer: superficial lamina propria, epithelium, Reinke*s space, vocal ligament, vocalis muscle) on structured histopathologic examination. - Anteroposterior tumour extension, lateral tumour extension (mm), infiltration depth (mm) and estimated tumour volume (cc) on Computed Tomography, after delineation of the tumour by an experienced head and neck radiologist.	—

Measure

Time frame

To assess the feasibility of the clinical use of 3T MR imaging of early laryngeal carcinoma; - Systematic assessment of technical image quality and assessment of tumour visibility on 3T MRI. - Anteroposterior tumour extension, lateral tumour extension (measured from free edge of the vocal fold in mm), estimated tumour infiltration depth (mm) and estimated tumour volume (cc) after delineation of the tumour at 3T MRI by an experienced head and neck radiologist. - Anteroposterior tumour extension and lateral tumour extension (measured from free edge of the vocal fold in mm) during direct suspension laryngoscopy (reference standard). - Tumour infiltration depth (in mm and invasion of tissue layer: superficial lamina propria, epithelium, Reinke*s space, vocal ligament, vocalis muscle) on structured histopathologic examination. - Anteroposterior tumour extension, lateral tumour extension (mm), infiltration depth (mm) and estimated tumour volume (cc) on Computed Tomography, after delineation of the tumour by an experienced head and neck radiologist.

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Countries

Netherlands

Outcome results