Evidence map›Paper›PMID 39760796›Full record

ArticleJournal of neuro-oncology2025

A phase I study of convection-enhanced delivery (CED) of liposomal-irinotecan using real-time magnetic resonance imaging in patients with recurrent high-grade glioma.

Kazim H Narsinh, Karishma Kumar, Krystof Bankiewicz, Alastair J Martin, Mitchell Berger, Jennifer Clarke, Jennie Taylor, Nancy Ann Oberheim Bush, Annette M Molinaro, Manish Aghi and 1 more

Abstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of neuro-oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

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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

11 authors.

Kazim H NarsinhDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA. kazim.narsinh@ucsf.edu.
Karishma KumarDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
Krystof BankiewiczDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
Alastair J MartinDepartment of Radiology & Biomedical Imaging, San Francisco, CA, USA.
Mitchell BergerDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
Jennifer ClarkeDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
Jennie TaylorDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
Nancy Ann Oberheim BushDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
Annette M MolinaroDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
Manish AghiDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
Nicholas ButowskiDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA. nicholas.butowski@ucsf.edu.

Funding

Retroviral RLI immunomodulatory gene therapy for glioblastomaR01NS123808 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Manish Aghi · 2022 to 2026
$2.1M
A Phase I Study of CED of Liposomal-Irinotecan using imaging in High Grade GliomaR21CA186140 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BUTOWSKI, NICHOLAS A · 2014 to 2015
$651k
NCI NIH HHS R21 CA186140NIH HHS 5R21CA186140-02NINDS NIH HHS R01 NS123808
6 · The paper itself

Abstract

backgroundIrinotecan demonstrates anti-tumor efficacy in preclinical glioma models but clinical results are modest due to drug delivery limitations. Convection enhanced delivery (CED) improves drug delivery by increasing intratumoral drug concentration. Real-time magnetic resonance imaging of infusate delivery during CED may optimize tumor coverage. This phase 1 trial examines the safety and tolerability of liposomal irinotecan and gadolinium delivered via CED using real-time MRI guidance in recurrent high-grade glioma patients.

methodsInitially, a 3 + 3 dose-escalating, single dose trial was planned with 4 cohorts based on a fixed drug dose and volume. After 9 patients, a protocol amendment allowed for variable volume and dose of the study agent based on tumor size. The amended design specified 'personalized' drug volume but fixed concentration of 20 mg/mL of liposomal irinotecan in the first cohort escalating to 40 mg/mL in the second cohort.

resultsEighteen patients with recurrent WHO grade 3 or 4 gliomas (diameter 1-4 cm) were treated. Based on the tumor volume, the total dose of liposomal irinotecan was 20-680 mg in a total volume of 2-17 ml. Technical challenges were overcome by real-time MRI guidance and protocol amendment. The only dose-limiting toxicity (DLT) was a grade 3 stroke. Safety and survival information is presented.

conclusionsCED of liposomal irinotecan using real-time MRI in patients with recurrent high-grade glioma is feasible. Image-guidance allowed for improved placement of CED cannulas and optimal tumor coverage. Our results warrant further study with repeat CED dosing.

Indexed as

Brain NeoplasmsCamptothecinDrug Delivery SystemsGliomaMagnetic Resonance ImagingNeoplasm Recurrence, LocalAdultAgedConvectionFemaleGadoliniumHumansIrinotecanLiposomesMaleMiddle AgedCamptothecinGadoliniumIrinotecanLiposomesAnaplastic astrocytomaCEDConvection enhanced deliveryGlioblastomaGliosarcomaHigh grade gliomasLiposomal irinotecanMRIMultiply recurrentNano-liposomal irinotecanOligodendrogliomaRecurrent

Identifiers

PMID39760796
PMCPMC11832582

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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.