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An explorative study to assess novel measurement methods for evaluating speech and swallowing function in healthy volunteers and patients with tongue carcinoma (stage I-II)

An explorative study to assess novel measurement methods for evaluating speech and swallowing function in healthy volunteers and patients with tongue carcinoma (stage I-II) - DICTIE-study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57291
Enrollment
20
Registered
2023-11-16
Start date
2025-08-28
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Tongue cancer, oral cancer Tongue cancer

Interventions

MRI, OPG

Sponsors

Antoni van Leeuwenhoek (AVL)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers: In order to be eligible to participate in this study, healthy volunteers will participate who are able to understand the research requirements and who will sign an informed consent form. The age of volunteers is between 18-80 years old at the time of signing the informed consent. To participate in this study, subjects must be able to read, speak and understand the Dutch language. Patients: In order to be eligible to participate in this study, a patient must meet all following criteria: patients over 18 years of age with newly diagnosed T1-T2 N0 squamous cell carcinoma of the tongue that will be planned for curative therapy, a partial glossectomy with primary closure or free flap reconstruction. To participate in this study subjects must be able to read, speak and understand the Dutch language, the participant information and the informed consent.

Exclusion criteria

Exclusion criteria: Healthy volunteers: Exclusion criteria are metal braces, dental splints, or any general MRI  contraindication. Patients: A potential patient who meets any of the following criteria will be excluded  from participation in this study:  - Postoperative radiation therapy - ASA IV or V - Absolute contraindications for MRI (e.g. pacemaker, ICD or surgery in the  last 6 months) - Orthodontic braces - Pregnancy or potential pregnancy - Claustrophobic or anxious during MRI - Orthopnea - Unable to lie down and lie still for 30 minutes

Design outcomes

Primary

MeasureTime frame
In the first part of the study the main study parameter is the feasibility and repeatability of an advanced 3D-dMRI to depict speech and swallowing. In the second part of the study the main endpoint is the feasibility of 3D-dMRI, manofluorography, and OPG to detect differences in speech and swallowing function before and after surgery of tongue cancer.

Countries

Netherlands

Contacts

Public ContactL. Molen

Antoni van Leeuwenhoek (AVL)

l.vd.molen@nki.nl0205122550

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026