Multispectral Fluorescence as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies in Prostate Cancer. (SPLIT)

Netherlands Cancer Institute (NKI)

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: multispectral imaging; Procedure: fluorescence for lymphatic mapping

Study type: Observational

Funder types: Other

Identifiers

NCT05120973

N21SPL

Details and patient eligibility

About

Multispectral imaging of the lymphatic draining pattern of the tumor and the abdominall wall/lower limb to evaluate technical feasibility to differentiate these patterns and in the future reduce the amount of complications that result from damage to lymphatic structures.

Full description

By preventing unnecessary resection of healthy lymphatic tissue during extended lymph node dissections, the investigators will be able to reduce the degree and amount of complications that result from damage to the lymphatic structures. The investigators aim to evaluate the technical feasibility of imaging two different lymphatic drainage profiles, namely that of healthy tissue (i.e. the lower limbs/abdominal wall) and that of the primary tumour (i.e. prostate). To realize the differentiation, real-time multispectral fluorescence imaging of two spectrally different tracers (the lymphangiographic tracer fluorescein (injected in the lower limbs and abdominal wall) and sentinel node (SN) specific tracer Indocyanine Green (ICG)-99mTc-nanocolloid (injected in the tumour, followed by a control lymphoscintigraphy and SPECT/CT)) will allow for multispectral (or multicolor) fluorescence. Complementary to the routine surgical procedure, e.g. radical prostatectomy with extended pelvic lymph node dissection (ePLND), the lymphatic drainage pattern of both the tumour and of healthy tissue, i.e. lower limbs and abdominal wall, will be determined in the surgical field/surgical specimens.

Enrollment: 26 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Group A:

• Male, aged ≥ 18 years.
• WHO performance status 0,1, or 2.
• Written informed consent.
• Histopathologically confirmed adenocarcinoma of the prostate
• Increased risk of nodal metastases according to the Briganti 2012 nomogram (> 7%)
• Scheduled for surgical (laparoscopic) prostatectomy including ePLND-
• Suitable for RP and ePLND, as per institutional guidelines

Exclusion Criteria Group A:

• Prior abdominal or inguinal surgery (e.g. appendectomy)
• History of allergy to iodine, food or medicinal induced urticaria, asthma, eczema, or allergic rhinitis
• Hyperthyroid or thyroidal adenoma
• Kidney insufficiency
• History of oversensitivity to FLUORESCITE composites
• Patients using beta-blockers

Inclusion Criteria Group B:

• Male, aged ≥ 18 years.
• WHO performance status 0,1, or 2.
• Written informed consent.
• Histopathologically confirmed adenocarcinoma of the prostate
• Increased risk of nodal metastases according to the Briganti 2012 nomogram (> 15%)
• Scheduled for surgical (laparoscopic) prostatectomy including ePLND-
• Suitable for RP and ePLND, as per institutional guidelines

Exclusion Criteria Group B:

• Prior abdominal or inguinal surgery (e.g. appendectomy)
• History of allergy to iodine, food or medicinal induced urticaria, asthma, eczema, or allergic rhinitis
• Hyperthyroid or thyroidal adenoma
• Kidney insufficiency

Trial design

26 participants in 2 patient groups

A

Description:

Tc-ICG in the prostate (SN procedure) and fluorescein unlilateral in leg or abdominal wall

Treatment:

Procedure: multispectral imaging

B

Description:

Free ICG bilateral in the abdominal wall

Treatment:

Procedure: fluorescence for lymphatic mapping