Prostate CancerSPLITNCT05120973
Multispectral Fluorescence as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies in Prostate Cancer.
An observational study of Prostate Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- multispectral imaging and fluorescence for lymphatic mapping
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2021to 24 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men >18 yrs with primary diagnosed prostate cancer eligible for robot assisted radical prostatectomy and lymph node dissection
Who may be able to join
- 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-
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: MultiSPectral fLuorescence Imaging as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies During Lymph Node Dissections in Prostate Cancer.
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- multispectral imaging, fluorescence for lymphatic mapping
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multispectral imagingProcedure or surgery
Sentinel node biopsy with Indocyanine Green -Technetium - Nanocolloid + fluorescein
fluorescence for lymphatic mappingProcedure or surgery
Indocyanine green injected in abdominal wall
| Study group | Role | What they receive |
|---|---|---|
| A | Tc-ICG in the prostate (SN procedure) and fluorescein unlilateral in leg or abdominal wall Receives: Procedure: multispectral imaging | |
| B | Free ICG bilateral in the abdominal wall Receives: Procedure: fluorescence for lymphatic mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of this intraoperative visualisation technique
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
Measured: During surgery
Secondary outcomes (1)
Anatomic localisation
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.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Nov 2021
- Primary completion25 Apr 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henk van der Poel, Prof. MD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120973
- Sponsor's protocol ID
- N21SPL
- Acronym
- SPLIT
- Status last verified
- Sep 2023
- First submitted
- 3 Nov 2021
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berrens AC, van Oosterom MN, Slof LJ, van Leeuwen FWB, van der Poel HG, Buckle T. Three-way multiplexing in prostate cancer patients - combining a bimodal sentinel node tracer with multicolor fluorescence imaging. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1262-1263. doi: 10.1007/s00259-022-06034-x. Epub 2022 Nov 19. No abstract available.
PubMed 36401635
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MultiSPectral fLuorescence Imaging as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies During Lymph Node Dissections in Prostate Cancer.
- ClinicalTrials.gov ID
- NCT05120973
- Acronym / sponsor ID
- SPLIT / N21SPL
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: multispectral imagingTc-ICG in the prostate (SN procedure) and fluorescein unlilateral in leg or abdominal wall |
| B | – | Procedure: fluorescence for lymphatic mappingFree ICG bilateral in the abdominal wall |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men >18 yrs with primary diagnosed prostate cancer eligible for robot assisted radical prostatectomy and lymph node dissection
Key inclusion criteria (14 listed)
- 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%)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multispectral imagingSentinel node biopsy with Indocyanine Green -Technetium - Nanocolloid + fluorescein | Procedure or surgery | A |
| fluorescence for lymphatic mappingIndocyanine green injected in abdominal wall | Procedure or surgery | B |
Primary outcome
Feasibility of this intraoperative visualisation technique
Time frame: 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
1 secondary outcome
Anatomic localisation
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Results publication: PubMed 36401635Berrens AC, van Oosterom MN, Slof LJ, van Leeuwen FWB, van der Poel HG, Buckle T. Three-way multiplexing in prostate cancer patients - combining a bimodal sentinel node tracer with multicolor fluorescence imaging. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1262-1263. doi: 10.1007/s00259-022-06034-x. Epub 2022 Nov 19. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henk van der Poel, Prof. MD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of this intraoperative visualisation technique (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05120973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.