Prostate Cancer
Conditions
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREmultispectral imaging
Sentinel node biopsy with Indocyanine Green -Technetium - Nanocolloid + fluorescein
PROCEDUREfluorescence for lymphatic mapping
Indocyanine green injected in abdominal wall
Sponsors
The Netherlands Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of this intraoperative visualisation technique | During surgery | The ability to visually differentiate the draining lymphatics of the lower limbs and abdominal wall, (LNLower limb/abdominal wall; fluorescein) from the disease associated LNs (LNprostate cancer; ICG-99mTc-nanocolloid) during lymph node dissection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomic localisation | During surgery | Determine the anatomical relationship between lymphatic tumour spread and the lymphatic drainage profiles of the lower limbs and primary tumour (i.e. prostate) in relation to ePLND template. |
Countries
Netherlands
Outcome results
None listed