Prostate CancerNCT02163083
Detection of Lymphnodes Using ICG During RARP
A study testing ICG in people with Prostate Cancer, run by St. Antonius Hospital Gronau at 1 site in Germany.
Trial summary
The purpose of this study is to investigate, whether the detection of lymph nodes by means of intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted radical prostatectomy is higher than without the use of indocyanine green (ICG). Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ICG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Apr 2017
- Phase
- Interventional
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed locally limited prostate cancer;
- Intermediate or high risk tumor
- Recommended and planned prostatectomy;
- Completed and signed written consent;
- Voluntarily agreement to participate in this study
- Age of the study participants ≥ 18 years.
Who cannot join
- Allergic reaction to active ingredient (indocyanine green);
- Iodine allergy;
- Hyperthyroidism;
- High-grade renal impairment;
- High-grade hepatic insufficiency;
- Unwillingness to the storage and disclosure of pseudonymous disease and personal data
- psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question
Trial locations and contacts
1 site in 1 country.
Germany1 site
St. Antonius Hospital Gronau, Department for Urology, Pediatric Urology and Urologic Oncology
Gronau, Moellenweg 22, 48599
About this study
Official title: Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy
The purpose of this study is to investigate, whether the detection of lymph nodes by means of intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted radical prostatectomy is higher than without the use of indocyanine green (ICG).
Read the detailed description
ICG is a fluorescent dye that fluoresces green bound to proteins under illumination in the near-infrared range. Using this dye allows to visualize lymphatic nodes, by being injected into the tumor or directly surrounding tissue.
- Conditions
- Prostate Cancer
- Being tested
- ICG
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICGProcedure or surgery
Also called indocyanine green powder, Pulsion Medical Systems, München, Germany
Improvement of detection of positive lymphnodes
| Study group | Role | What they receive |
|---|---|---|
| Lymphadenectomy using standard Methods | No intervention | Lymphadenectomy will be performed as a standard procedure |
| Lymphadenectomy using ICG | Experimental | A fluorescent dye (indocyanine green) will be ultrasound-controlled preoperatively injected in the prostate. During robot-assisted radical intervention by DaVinci ® robot the lymphadenectomy is performed using the fluorescence lymphography. Receives: Procedure: ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total number of detection rate of (positive) lymph nodes using ICG
Measured: during the surgery
Secondary outcomes (1)
Measurements of the time, that takes to remove the lymph nodes
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital Gronau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörn H. Witt, MD, Principal investigator, St. Antonius Hospital Gronau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163083
- Sponsor's protocol ID
- U1111-1157-6624
- Other IDs
- 2013-609-f-S
- Status last verified
- Jan 2019
- First submitted
- 10 Jun 2014
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy
- ClinicalTrials.gov ID
- NCT02163083
- Acronym / sponsor ID
- U1111-1157-6624
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- St. Antonius Hospital GronauUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 13 Jun 2014 (estimated)
- 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.
The purpose of this study is to investigate, whether the detection of lymph nodes by means of intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted radical prostatectomy is higher than without the use of indocyanine green (ICG).
Detailed description
ICG is a fluorescent dye that fluoresces green bound to proteins under illumination in the near-infrared range. Using this dye allows to visualize lymphatic nodes, by being injected into the tumor or directly surrounding tissue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphadenectomy using standard Methods | No intervention | –Lymphadenectomy will be performed as a standard procedure |
| Lymphadenectomy using ICG | Experimental | Procedure: ICGA fluorescent dye (indocyanine green) will be ultrasound-controlled preoperatively injected in the prostate. During robot-assisted radical intervention by DaVinci ® robot the lymphadenectomy is performed using the fluorescence lymphography. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed locally limited prostate cancer;
- Intermediate or high risk tumor
- Recommended and planned prostatectomy;
- Completed and signed written consent;
- Voluntarily agreement to participate in this study
Key exclusion criteria (7 listed)
- Allergic reaction to active ingredient (indocyanine green);
- Iodine allergy;
- Hyperthyroidism;
- High-grade renal impairment;
- High-grade hepatic insufficiency;
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 |
|---|---|---|
| ICGAlso: indocyanine green powder, Pulsion Medical Systems, München, GermanyImprovement of detection of positive lymphnodes | Procedure or surgery | Lymphadenectomy using ICG |
Primary outcome
The total number of detection rate of (positive) lymph nodes using ICG
Time frame: during the surgery
1 secondary outcome
Measurements of the time, that takes to remove the lymph nodes
Time frame: During the 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 18 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Not yet recruitingObservational study
Assessment of Intelligent Algorithms for Detection, Diagnosis and Risk Stratification of Tumors of the Kidney and Prostate
Kidney Cancers, Prostate Cancer
Not yet recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Castration Resistant Metastatic Prostate Cancer, Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
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.
Jörn H. Witt, MD principal investigator
St. Antonius Hospital Gronau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG in people with Prostate Cancer, run by St. Antonius Hospital Gronau at 1 site in Germany.
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 6 inclusion and 7 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 18 Jan 2019. 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 Germany. 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?
The total number of detection rate of (positive) lymph nodes using ICG (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2019.