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

Recruiting

Conditions: Oral cancer
tongue cancer
10019190

Registration Number: NL-OMON52144

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

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

• 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We hypothesized that in 80% of the patients the tumor is entirely visible with<br /><br>intra-operative in-vivo ultrasound assessed by two observers, the surgeon and<br /><br>the researcher. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Evaluating the correlation between resection margins by intraoperative 3D<br /><br>reconstructed ultrasound and pathologic outcomes in oral cavity surgery.</p><br>