NCT05120973Completed
Multispectral Fluorescence as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies in Prostate Cancer.
MultiSPectral fLuorescence Imaging as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies During Lymph Node Dissections in Prostate Cancer.
Source: ClinicalTrials.gov · Last updated 29 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 26 (actual)
- First submitted
- 3 Nov 2021
- Start date
- 1 Nov 2021
- Primary completion date
- 25 Apr 2024
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Prostate cancer
- NCT number
- NCT05120973
What you commit to
- Study type: Observational
- Participants enrolled: 26
- From 1 Nov 2021 to the primary completion date, 25 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior abdominal or inguinal surgery (e.g. appendectomy)
- Prior abdominal or inguinal surgery (e.g. appendectomy)
Other illness
- History of allergy to iodine, food or medicinal induced urticaria, asthma, eczema, or allergic rhinitis
- Kidney insufficiency
- History of oversensitivity to FLUORESCITE composites
- History of allergy to iodine, food or medicinal induced urticaria, asthma, eczema, or allergic rhinitis
- Kidney insufficiency
Other
- Hyperthyroid or thyroidal adenoma
- Patients using beta-blockers
- Hyperthyroid or thyroidal adenoma
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.