Clinical trial NCT03106038: Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Intraoperative Ureter Injury
Keywords: contrast agent
ureter imaging
intraoperative monitoring
intraoperative procedures
near infrared fluorescence
minimally invasive
Lead sponsor: Li-Cor, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-10
Enrollment: 41
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: beginning at the estimated target dose, the dosage was increased and decreased to confirm the near-optimal dose.
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

  * 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.

Primary outcomes:
measure: Treatment-Emergent Adverse Events
timeFrame: 30 days
measure: Dose response
timeFrame: 10 minutes through 90 minutes post administration
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Women & Infants Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Kenneth H. Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.