Photoacoustic imaging of sentinel lymph nodes, a feasibility study

• Conditions: metastasis; Sentinel lymph node; 10006232; 10040900; 10041297

• Registration Number: NL-OMON56703
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

Arm 1: Volunteers:
• 18 years and older,
• No history of lymph node surgery
• Willingness of participation: signed informed consent

Phase 2:
Arm 2: Subject who will undergo SLNB for melanoma or breast cancer
• 18 years and older
• Melanoma stage 1b or higher or breast cancer
• Indication for SLNB
• Willingness of participation: signed informed consent
• Melanoma not located on the head and neck

Arm 3: Subject who will undergo SLNB for head or neck melanoma
• 18 years and older
• Melanoma located on the head and neck
• Melanoma stage 1b or higher
• Indication for SLNB
• Willingness of participation: signed informed consent

Exclusion Criteria

• Presence of an allergic history for iodine,
• Patients where NIR imaging cannot be performed,
• Pregnancy
• Incapacitated subjects

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>• Do we observe SLN with laser-based PAI? (yes/no)<br /><br>• Which amount of SLN were detected with laser-based PAI? (numbers)<br /><br>• Do we observe SLN with LED-based PAI? (yes/no)<br /><br>• Which amount of SLN were detected with LED-based PAI? (numbers)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• The depth of the observed SLN in millimetres<br />• Is the SLN detected with both PAI systems at various times after injection?<br />(yes/no) (phase 1)<br />• Do we observe SLN similar to those observed with NIR camera? (yes/no)<br />• Obtain of PAI images with the laser system at different wavelength of the<br />SLNs.<br />• Diameter of the detected SLN observed with the PAI systems in millimetres.<br />• Is the SLN location similar between the PAI systems and the Technetium?<br />(yes/no)<br />• Are the resected SLNs fluorescent with the NIR camera? (yes/no)<br />• Contain the resected SLNs technetium?(yes/no)<br />• The distance between the Ultraviolet marker and the incision in millimetres </p>