FDG-PET/CT to reduce the need for sentinel lymph node biopsy in early-stage oral cancer.

Recruiting

• Conditions: 10027476; oral cancer; Oral squamous cell carcinoma

• Registration Number: NL-OMON53440
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 159

Inclusion Criteria

To be eligible to participate in this study, a subject must meet all of the
following criteria:
• Newly diagnosed early-stage OSCC is defined as clinically T1-3, N0 (only when
T3 is assessed based on tumor dimensions of >2 cm and <=4 cm with DOI >10 mm)
• The patient is >=18 years of age at the time of consent.
• The patient has no palpable lymph nodes in the neck.
• Clinical nodal staging (cN0) has been confirmed by ultrasound, CT, and/or MRI
if performed (not mandatory).
• The patient is a candidate for transoral excision and SLNB.
• The patient has provided written informed consent authorization before
participating in the study.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• The patient has other pathologies than squamous cell carcinoma;
• The patient has recurrent primary oral squamous cell carcinoma;
• The patient has a history of treatment of the neck (neck dissection and/or
radiotherapy);
• The patient has ultrasound guided fine needle aspiration cytology positive
for lymph node metastasis;
• The patient has poorly controlled diabetes mellitus;
• The patient refused preoperative imaging workups.

A potential subject who meets the following criteria will only be excluded for
the contrast-enhanced CT of the head and neck:
• The patient has had a previous allergic reaction after administration of
contrast fluid.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to reduce the need for SLNB by<br /><br>FDG-PET/CT in cN0 OSCC patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To optimize scoring criteria for the detection of (occult) lymph node<br />metastases by FDG-PET/CT with a high positive predictive value.<br />• To assess the sensitivity, specificity, PPV, negative predictive value and<br />accuracy for the different scoring criteria.<br />• To investigate inter-observer agreement before and after scoring criteria are<br />established.<br />• To compare the quality of life and costs in three different diagnostic<br />scenarios 1) PET/CT, 2) SLNB, and 3) PET/CT and, only if negative, SLNB.<br />• To obtain insight into patients* preferences and experience of the diagnostic<br />procedures.</p>