Evidence map›Paper›PMID 33243800›Full record

ArticleBMJ open2020

Phase I feasibility study of Magnetic Resonance guided High Intensity Focused Ultrasound-induced hyperthermia, Lyso-Thermosensitive Liposomal Doxorubicin and cyclophosphamide in

Josanne S de Maar, Britt B M Suelmann, Manon N G J A Braat, P J van Diest, H H B Vaessen, Arjen J Witkamp, S C Linn, Chrit T W Moonen, Elsken van der Wall, Roel Deckers

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03749850 (Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer. Phase I Feasibility Study of Hifu-Induced Hyperthermia, LTLD and Cyclophosphamide for Metastatic Breast Cancer), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
1.6field-weighted citation impact, top 18% 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.

NCT03749850 phase1unknown statusnot on this mapstarted 2021, after this paper: background citation

Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer. Phase I Feasibility Study of Hifu-Induced Hyperthermia, LTLD and Cyclophosphamide for Metastatic Breast Cancer

TypeinterventionalSponsorUMC UtrechtRan2021 to 2022Enrolled12ConditionsMetastatic Breast Cancer, Breast Cancer, Breast Neoplasms, Stage IV Breast CancerArmsLTLD, MR-HIFU induced hyperthermia, Cyclophosphamide
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 29 citations in OpenAlex.

  1. Advancements in Intraoperative Imaging for Enhanced Surgical Precision.Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer · 2026
    Review
  2. Review
  3. Review
  4. Smart Cancer Nanomedicine for Synergetic Therapy.Current medicinal chemistry · 2025
    Review
  5. Review
  6. MR Imaging-Guided Focused Ultrasound for Breast Tumors.Magnetic resonance imaging clinics of North America · 2024
    Review
  7. Article
  8. Review
  9. Liposomes for Tumor Targeted Therapy: A Review.International journal of molecular sciences · 2023
    Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Deployable ultrasound applicators for endoluminal delivery of volumetric hyperthermia.International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group · 2021
    Article
  16. Recent advances in liposome formulations for breast cancer therapeutics.Cellular and molecular life sciences : CMLS · 2021
    Review
  17. Article
  18. Ablative Therapies for Breast Cancer: State of Art.Technology in cancer research & treatment
    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

10 authors at 3 institutions in 1 country.

Josanne S de MaarDivision of Imaging and Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands j.s.demaar@umcutrecht.nl.ORCID 0000-0002-7493-4215
Britt B M SuelmannDivision of Imaging and Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Manon N G J A BraatDivision of Imaging and Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
P J van DiestDepartment of Pathology, University Medical Center Utrecht, Utrecht, The Netherlands.
H H B VaessenDepartment of Anesthesiology, University Medical Center Utrecht, Utrecht, The Netherlands.
Arjen J WitkampDivision of Imaging and Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
S C LinnDivision of Imaging and Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Chrit T W MoonenDivision of Imaging and Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Elsken van der WallDivision of Imaging and Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Roel DeckersDivision of Imaging and Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Utrecht University · NLUniversity Medical Center Utrecht · NLThe Netherlands Cancer Institute · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn breast cancer, local tumour control is thought to be optimised by administering higher local levels of cytotoxic chemotherapy, in particular doxorubicin. However, systemic administration of higher dosages of doxorubicin is hampered by its toxic side effects. In this study, we aim to increase doxorubicin deposition in the primary breast tumour without changing systemic doxorubicin concentration and thus without interfering with systemic efficacy and toxicity. This is to be achieved by combining Lyso-Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox, Celsion Corporation, Lawrenceville, NJ, USA) with mild local hyperthermia, induced by Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU). When heated above 39.5°C, LTLD releases a high concentration of doxorubicin intravascularly within seconds. In the absence of hyperthermia, LTLD leads to a similar biodistribution and antitumour efficacy compared with conventional doxorubicin. METHODS AND ANALYSIS: This is a single-arm phase I study in 12 chemotherapy-naïve patients with ETHICS AND DISSEMINATION: This study has obtained ethical approval by the Medical Research Ethics Committee Utrecht (Protocol NL67422.041.18, METC number 18-702). Informed consent will be obtained from all patients before study participation. Results will be published in an academic peer-reviewed journal. TRIAL REGISTRATION NUMBERS: NCT03749850, EudraCT 2015-005582-23.

Indexed as

Breast NeoplasmsCyclophosphamideDoxorubicinCanadaClinical Trials, Phase I as TopicFeasibility StudiesHumansHyperthermiaMagnetic Resonance SpectroscopyPolyethylene GlycolsTissue DistributionCyclophosphamideDoxorubicinliposomal doxorubicinPolyethylene Glycolsbreast tumourschemotherapyinterventional radiologymagnetic resonance imagingoncologyultrasound

Identifiers

PMID33243800
PMCPMC7692846
OpenAlexW3109702364

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.