Evidence map›Paper›PMID 35346070›Full record

ArticleBMC gastroenterology2022

A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of

Armeen Mahvash, Steven Chartier, Mark Turco, Paula Habib, Steven Griffith, Scott Brown, S Cheenu Kappadath

Registry-linked trialOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in BMC gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04736121 (A Prospective, Multicenter, Open-label Single Arm Study Evaluating the Safety & Efficacy of Selective Internal Radiation Therapy Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.7field-weighted citation impact, top 16% 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.

NCT04736121 naactive not recruitingnot on this map

A Prospective, Multicenter, Open-label Single Arm Study Evaluating the Safety & Efficacy of Selective Internal Radiation Therapy Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients

TypeinterventionalSponsorSirtex MedicalRan2021 to 2026Enrolled100ConditionsUnresectable Hepatocellular Carcinoma, BCLC Stage A Hepatocellular Carcinoma, BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular CarcinomaArmsResin microspheres containing yttrium-90 (Y-90)
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Review
  3. MRI radiomics andBMC cancer · 2026
    Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Predictive Value of [Diagnostics (Basel, Switzerland) · 2023
    Article
  10. Observational
  11. Review
  12. Review
  13. Article
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 2 institutions in 1 country.

Armeen MahvashDepartment of Interventional Radiology, Unit 1471, University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, 77030, USA. armeen.mahvash@mdanderson.org.ORCID http://orcid.org/0000-0003-0416-4566
Steven ChartierSirtex, Woburn, MA, USA.
Mark TurcoSirtex, Woburn, MA, USA.
Paula HabibSirtex, Woburn, MA, USA.
Steven GriffithSirtex, Woburn, MA, USA.
Scott BrownBRIGHT Research Partners, Minneapolis, MN, USA.
S Cheenu KappadathDepartment of Imaging Physics, University of Texas MD Anderson Cancer Center, 1155 Pressler Street, Unit 1352, Houston, TX, 77030, USA. skappadath@mdanderson.org.ORCID http://orcid.org/0000-0003-4643-7745
The University of Texas MD Anderson Cancer Center · USLake Research Partners · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSelective internal radiation therapy (SIRT) with yttrium-90 (

methodsEligibility criteria include unresectable/unablatable HCC, Barcelona Clinic Liver Cancer stage A, B1, B2, or C with a maximal single tumor diameter of ≤ 8 cm, and a sum of maximal tumor diameters of ≤ 12 cm, and at least one tumor ≥ 2 cm (long axis) per localized, modified Response Evaluation Criteria in Solid Tumors. Partition model dosimetry is used to determine the optimal dose; the target mean dose to tumor is ≥ 150 Gy. Patients are assessed at baseline and at regular intervals up until 12 months of treatment for response rates, safety, and quality of life (QoL). Post-treatment dosimetry is used to assess dose delivered to tumor and consider if retreatment is necessary. The co-primary endpoints are best objective response rate and duration of response. Secondary endpoints include grade ≥ 3 toxicity, QoL, and incidence of liver resection and transplantation post SIRT. Target recruitment is 100 patients. DISCUSSION: The results of this trial should provide further information on the potential use of SIRT with

trial registrationClinicaltrials.gov; NCT04736121; date of 1st registration, January 27, 2021, https://clinicaltrials.gov/ct2/show/NCT04736121 .

Indexed as

Carcinoma, HepatocellularLiver NeoplasmsClinical Trials as TopicHumansMicrospheresProspective StudiesQuality of Life90Y resin microspheresHepatocellular carcinoma (HCC)RadioembolizationSIRT

Identifiers

PMID35346070
PMCPMC8962126
OpenAlexW4221033131

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.