A prototype opto-nuclear probe for combined radio- and fluorescence tracing of the sentinel node

• Conditions: schildwachtklieronderzoek bij hoofd-hals maligniteiten (M/V), penis en prostaat kanker; sentinel node biopsy

• Registration Number: NL-OMON40822
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Patients > 18 years of age;
- Patients with histologically proven head and neck malignancies;
- Patients with histologically proven penile cancer;
- Patients with histologically proven prostate cancer;
- Patients are clinically N0M0 (penile cancer: N0M0 or N1M0);
- For head and neck malignancies and penile cancer patients only: Patients are scheduled for (primary) tumor (scar) removal with a subsequent sentinel node biopsy;
- For prostate cancer patients only: Patients with an increased risk of nodal metastases according to the Briganti nomogram (>10%);
- For prostate cancer patients only: Patients are scheduled for (robot-assisted) laparoscopic prostatectomy with a subsequent sentinel node biopsy procedure and selective lymph node dissection.

Exclusion Criteria

- History of iodine allergy;
- Hyperthyroid or thyroidal adenoma;
- Kidney insufficiency.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The intraoperative sentinel node identificaton rate using the opto-nuclear<br /><br>probe via 1) gamma tracing; and 2) via fluorescence tracing. Obtained results<br /><br>will be compared tot hat of the gamma camera and the fluorescence camera<br /><br>(routinely used methods). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>