Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Floor of Mouth Squamous Cell Carcinoma
  • Tongue Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Clinical trialMasking: None (Open Label)Masking Description: The ultrasound examiner should not be aware of the results of the MRI.Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The first part of this study will try to answer if ultrasound can improve the preoperative measurement of depth of invasion in tongue cancer and floor of the mouth cancer. The study population is new patients meeting the eligibility criteria presented to the hospital for treatment. Participants will...

The first part of this study will try to answer if ultrasound can improve the preoperative measurement of depth of invasion in tongue cancer and floor of the mouth cancer. The study population is new patients meeting the eligibility criteria presented to the hospital for treatment. Participants will be enrolled only after accepting the oral and written information and signing the written consent paper. The examiner, one of three otorhinolaryngologists experienced in ultrasound, should be masked to the results of MRI. The first measurement is depth of invasion as well as thickness of the tumour in mm by palpation on awake patient. Thereafter the same measurements by ultrasound (BK Medical Medical flex focus 500, 18Mhz) with gel and protective cover is made with 0,5mm accuracy. Anesthetic gel or lingual block with carbocaine/adrenaline are provided as needed. At the time of surgery the measurements above are done again on the patient in narcosis before the resection. Images of the ultrasound measurements are saved for documentation. The results are compared to the corresponding measurements on MRI and also on PAD from the surgical specimen. PAD is considered gold standard. Power calculation with help of biostatistician yielded a sample size of 55 patients, using a paired test with a 0,050 one-sided significance level will have 80% power to reject the null hypothesis that the proportions are not equivalent. Analysis if ultrasound correctly classify the tumour´s DOI according to the TNM-classification 8th edition (<5mm, >5mm<10mm, >10mm) will be made. The second part of the study will investigate if ultrasound during the surgical procedure can improve the discrimination of the deep margin of the tumour and thereby increasing the chance better surgical margins. The mucosal margins are marked in the usual fashion and the resection begins. After one fourth of the resection has been made, ultrasound is used to check that the deep margin is at least 10mm. This is repeated after one half and three quarters of the resection. At the end of the surgery a final ultrasound examination is made on the surgical specimen. The margins obtained on PAD from resections done with ultrasound are compared to a matched retrospective group where the surgery was done without ultrasound.

Tracking Information

NCT #
NCT04059861
Collaborators
Not Provided
Investigators
Principal Investigator: Johan Knutsson, Assoc. Prof. Region Örebro County