Photoacoustic imaging of sentinel lymph nodes, a feasibility study

Photoacoustic imaging of sentinel lymph nodes, a feasibility study - Photoacoustic imaging of SLNs

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56703

Enrollment

Registered

2024-04-02

Start date

2024-04-05

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastasis Sentinel lymph node

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
• Do we observe SLN with laser-based PAI? (yes/no) • Which amount of SLN were detected with laser-based PAI? (numbers) • Do we observe SLN with LED-based PAI? (yes/no) • Which amount of SLN were detected with LED-based PAI? (numbers)	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results