Intraoperative Ureter InjuryPhase 1/2NCT03106038
Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery
A Phase 1/2 study testing Nerindocianine for Injection in people with Intraoperative Ureter Injury, run by Li-Cor, Inc. at 1 site in United States.
Trial summary
The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Intraoperative Ureter Injury
- What is being tested?
- Nerindocianine for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2017to 19 Nov 2018
- Phase
- Phase 1/2
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent prior to the initiation of study procedures
- Are > 18 years of age
- Women consented to undergo standard of care minimally invasive pelvic surgery (traditional laparoscopy and robotic surgery)
- Women who are expected to be admitted to the hospital following surgery for at least 24 hours
Who cannot join
- Are unwilling or unable to provide informed consent.
- Are unwilling or unable to comply with the requirements of the protocol.
- History of prior urologic surgery.
- History of prior pelvic surgery.
- History of known retroperitoneal fibrosis.
- Have any of the following screening laboratory values:
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- Hemoglobin ≤ 8.0 g/dL;
- Absolute neutrophil count (ANC) ≤ 1500/μL;
- Platelet count ≤ 100,000/μL;
- Serum creatinine ≥ 1.5 x the institutional upper limit of normal (IULN) creatinine;
- Serum bilirubin ≥ 1.5 x IULN;
- Aspartate transaminase (AST or serum glutamic oxaloacetic transaminase, SGOT) ≥ 2x IULN;• Alanine transaminase (ALT or serum glutamate pyruvate transaminase, SGPT) ≥ 2 x IULN.
- Females who are pregnant, lactating, or breastfeeding;
- Any other condition that, in the Investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy.
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Women & Infants Center
Birmingham, Alabama, 35233
About this study
Official title: A Phase I/IIa Dose-escalation Study to Evaluate the Use of an Investigational Imaging Agent for the Detection of Urologic Anatomy Via Near Infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery
The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.
- Conditions
- Intraoperative Ureter Injury
- Being tested
- Nerindocianine for Injection
- Keywords
- contrast agent, ureter imaging, intraoperative monitoring, intraoperative procedures, near infrared fluorescence, minimally invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerindocianine for InjectionDrug
Also called IRDye 800BK
Procedure: routine minimally invasive pelvic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Nerindocianine for Injection | Experimental | One Arm: Nerindocianine for Injection (Initial dosing cohort: 0.06 mg/kg body weight); solution, intravenous, one time administration during surgery. the study has only one arm. Receives: Drug: Nerindocianine for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events
Measured: 30 days
Dose response
Dose response based on the composite assessment of the anatomy and laterality for detection of pelvic ureter in women undergoing minimally invasive surgery
Measured: 10 minutes through 90 minutes post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start26 Apr 2017
- Primary completion19 Nov 2018
- Study completion19 Nov 2018
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 Intraoperative Ureter InjuryStudies 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 1/2
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Model description
- beginning at the estimated target dose, the dosage was increased and decreased to confirm the near-optimal dose.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Li-Cor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth H. Kim, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106038
- Sponsor's protocol ID
- LICOR-10417-01
- Status last verified
- Nov 2019
- First submitted
- 29 Mar 2017
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huh WK, Johnson JL, Elliott E, Boone JD, Leath CA 3rd, Kovar JL, Kim KH. Fluorescence Imaging of the Ureter in Minimally Invasive Pelvic Surgery. J Minim Invasive Gynecol. 2021 Feb;28(2):332-341.e14. doi: 10.1016/j.jmig.2020.06.022. Epub 2020 Jun 29.
PubMed 32615331
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Dose-escalation Study to Evaluate the Use of an Investigational Imaging Agent for the Detection of Urologic Anatomy Via Near Infrared Fluorescence Imaging in the Setting of Minimally Invasive Surgery
- ClinicalTrials.gov ID
- NCT03106038
- Acronym / sponsor ID
- LICOR-10417-01
- Conditions
- Intraoperative Ureter Injury
- Keywords
- contrast agent, ureter imaging, intraoperative monitoring, intraoperative procedures, near infrared fluorescence, minimally invasive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Li-Cor, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 10 Apr 2017 (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.
The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- beginning at the estimated target dose, the dosage was increased and decreased to confirm the near-optimal dose.
| Arm | Type | Receives |
|---|---|---|
| Nerindocianine for Injection | Experimental | Drug: Nerindocianine for InjectionOne Arm: Nerindocianine for Injection (Initial dosing cohort: 0.06 mg/kg body weight); solution, intravenous, one time administration during surgery. the study has only one arm. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provide written informed consent prior to the initiation of study procedures
- Are > 18 years of age
- Women consented to undergo standard of care minimally invasive pelvic surgery (traditional laparoscopy and robotic surgery)
- Women who are expected to be admitted to the hospital following surgery for at least 24 hours
Key exclusion criteria (14 listed)
- Are unwilling or unable to provide informed consent.
- Are unwilling or unable to comply with the requirements of the protocol.
- History of prior urologic surgery.
- History of prior pelvic surgery.
- History of known retroperitoneal fibrosis.
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 |
|---|---|---|
| Nerindocianine for InjectionAlso: IRDye 800BKProcedure: routine minimally invasive pelvic surgery. | Drug | Nerindocianine for Injection |
Primary outcome
Treatment-Emergent Adverse Events
Time frame: 30 days
Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events
Dose response
Time frame: 10 minutes through 90 minutes post administration
Dose response based on the composite assessment of the anatomy and laterality for detection of pelvic ureter in women undergoing minimally invasive 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 26 Nov 2019.
- Derived from this study: PubMed 32615331Huh WK, Johnson JL, Elliott E, Boone JD, Leath CA 3rd, Kovar JL, Kim KH. Fluorescence Imaging of the Ureter in Minimally Invasive Pelvic Surgery. J Minim Invasive Gynecol. 2021 Feb;28(2):332-341.e14. doi: 10.1016/j.jmig.2020.06.022. Epub 2020 Jun 29.
- Individual participant dataSharing planned: No
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.
Kenneth H. Kim, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nerindocianine for Injection in people with Intraoperative Ureter Injury, run by Li-Cor, Inc. at 1 site in United States.
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 4 inclusion and 14 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 26 Nov 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Treatment-Emergent Adverse Events (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT03106038, 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 26 Nov 2019; AzTrials last refreshed its copy on 26 Oct 2026.