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3D reconstructed ultrasound for intra-operative resection margins assessment, a pilot study

3D reconstructed ultrasound for intra-operative resection margins assessment, a pilot study - ULTRON study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52144
Enrollment
10
Registered
2022-04-01
Start date
2022-10-21
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Oral cancer tongue cancer

Interventions

None listed

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • T1-T3 (according to the AJCC/UICC TNM 8th edition) tongue squamous cell carcinoma in oral cavity • Any N stage (N0-3) • No distant metastasis (M0) • Histopathologically proven squamous cell carcinoma • Intention to treat with surgery with curative intention as advised by tumour board • Age >= 18 years at time of study entry • Written informed consent

Exclusion criteria

Exclusion criteria: • cT4 (according to the AJCC/UICC TNM 8th edition) tongue squamous cell carcinoma in oral cavity • Any other histopathology than squamous cell carcinoma • Tumour located or exceeding to other parts of the oral cavity / oropharynx than the tongue • Presence of distant metastasis • Physically ineligible for an operation • Intention to treat with primary (chemo)radiotherapy • History of psychiatric or psychological disability judged by the investigator to potentially hamper compliance with the study protocol and follow-up schedule

Design outcomes

Primary

MeasureTime frame
We hypothesized that in 80% of the patients the tumor is entirely visible with intra-operative in-vivo ultrasound assessed by two observers, the surgeon and the researcher.

Secondary

MeasureTime frame
Evaluating the correlation between resection margins by intraoperative 3D reconstructed ultrasound and pathologic outcomes in oral cavity surgery.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)