Evidence map›Paper›PMID 33677615›Full record

Trial reportCancer chemotherapy and pharmacology2021

Pharmacokinetics of UGN-101, a mitomycin-containing reverse thermal gel instilled via retrograde catheter for the treatment of low-grade upper tract urothelial carcinoma.

Ahmad Shabsigh, Nir Kleinmann, Angela B Smith, Douglas Scherr, Elyse Seltzer, Mark Schoenberg, Seth P Lerner

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02793128 (A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of UGN-101 on Ablation of Upper Urinary Tract Urothelial Carcinoma), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02793128 phase3completednot on this map

A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of UGN-101 on Ablation of Upper Urinary Tract Urothelial Carcinoma

TypeinterventionalSponsorUroGen Pharma Ltd.Ran2017 to 2020Enrolled71ConditionsCarcinoma, Transitional Cell, Transitional Cell Carcinoma of Renal PelvisArmsUGN-101 instillations
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 16 citations in OpenAlex.

  1. Review
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  6. Article
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  9. Smart Hydrogels for Advanced Drug Delivery Systems.International journal of molecular sciences · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 2 countries.

Ahmad ShabsighDepartment of Urology, The Ohio State University Comprehensive Cancer Center, 300 W 10th Ave, Columbus, OH, 43210, USA. Ahmad.Shabsigh@osumc.edu.ORCID 0000-0003-1376-4977
Nir KleinmannDepartment of Urology, Sheba Medical Center, Ramat Gan, Israel.
Angela B SmithDepartment of Urology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
Douglas ScherrDepartment of Urology, Weill Medical College of Cornell University, New York, NY, USA.
Elyse SeltzerUroGen Pharma, New York, NY, USA.
Mark SchoenbergUroGen Pharma, New York, NY, USA.
Seth P LernerScott Department of Urology, Baylor College of Medicine, Houston, TX, USA.
Albert Einstein College of Medicine · USBaylor College of Medicine · USCornell University · USSheba Medical Center · ILThe Ohio State University · USUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the pharmacokinetic properties of UGN-101, a mitomycin-containing reverse thermal gel used as primary chemoablative treatment for low-grade upper tract urothelial carcinoma (UTUC), in a subset of patients participating in a phase 3 clinical trial.

methodsPharmacokinetic parameters (C

resultsThe mean age of the six participants was 69 years; most were male (5/6) and Caucasian (5/6). Mean (SD) C

conclusionThe reverse thermal gel formulation of UGN-101 is associated with higher concentration and extended dwell time of mitomycin in contact with the urothelium of the upper urinary tract while limiting systemic absorption of mitomycin. REGISTRATION: NCT02793128; registered June 8, 2016.

Indexed as

AgedAged, 80 and overBiopsyCathetersFemaleGelsHumansMaleMiddle AgedMitomycinNeoplasm Recurrence, LocalUrinary TractUrologic NeoplasmsUrotheliumGelsMitomycinMitomycinPharmacokineticsUGN-101Upper tract urothelial carcinomaUTUC

Identifiers

PMID33677615
PMCPMC8110485
OpenAlexW3134184155

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.