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Near-infrared Fluorescence-Enhanced Identification of the Ureters using ZW800-1


- candidate number28701
- NTR NumberNTR7408
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mrt-2018
- Secondary IDsP17.125 
- Public TitleNear-infrared Fluorescence-Enhanced Identification of the Ureters using ZW800-1
- Scientific TitleNear-infrared Fluorescence-Enhanced Identification of the Ureters using ZW800-1
- ACRONYM
- hypothesisIntraoperative identification of the ureters is improved with ZW800-1 and fluorescence imaging
- Healt Condition(s) or Problem(s) studiedLower abdominal and pelvic laparoscopic surgeries, ZW800-1
- Inclusion criteria1) Patients >18 years old;
2) Patients scheduled and eligible for laparoscopic surgery in the lower abdominal or pelvic area;
3) Patients should be capable and willing to give informed consent before study specific procedures;
4) No unacceptable known cardiovascular or pulmonary disease, renal or liver dysfunction;
5) The screening ECG and laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant;
6) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- Exclusion criteriaPatients will be excluded if any of the criteria below apply:
1) History of a clinically significant allergy or anaphylaxis;
2) Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
3) Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 13-mrt-2018
- planned closingdate13-mrt-2019
- Target number of participants12
- InterventionsInjection ZW800-1 and fluorescence imaging during surgery
- Primary outcomeTo assess the feasibility of ZW800-1 in intraoperative detection of the urinary tract using the NIR fluorescence imaging system.
- Secondary outcomeTo define the optimal dose of ZW800-1 for intraoperative imaging of the urinary tract.
- Timepoints-
- Trial web site-
- status[default]
- CONTACT FOR PUBLIC QUERIESMD PhD A.L. Vahrmeijer
- CONTACT for SCIENTIFIC QUERIESMD PhD A.L. Vahrmeijer
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- PublicationsHak Soo Choi et al. Synthesis and In Vivo Fate of Zwitterionic Near-Infrared Fluorophores. Angew Chem Int Ed Engl. 2011 July 4; 50(28): 62586263.
- Brief summaryIatrogenic ureteral injury during abdominal surgery is a rare but serious complication with incidences varying from 0.7% to 10%. ZW800-1 is a novel fluorophore and in pre-clinical studies it has proven to be a valid agent for molecular imaging, due to low non-specific binding and uptake, and an exclusive renal clearance. More importantly, ZW800-1 has been proven safe. A phase 1 study has been conducted in healthy volunteers and based on the results we believe ZW800-1 is an ideal candidate to visualize the urinary tract during surgery to prevent iatrogenic ureteral damage.
- Main changes (audit trail)
- RECORD13-mrt-2018 - 10-aug-2018


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