Phase I-II study of intra-operative high intensity focused ultrasound in 25 patients with colorectal liver metastase

2015 ◽  
Vol 137 (4) ◽  
pp. 2399-2399
Author(s):  
David Melodelima ◽  
Aurelien Dupre ◽  
David Perol ◽  
Yao Chen ◽  
Jeremy Vincenot ◽  
...  
Keyword(s):  
Phase I ◽  
High Intensity ◽  
Focused Ultrasound ◽  
High Intensity Focused Ultrasound

Phase I/II Trial of High Intensity Focused Ultrasound for the Treatment of Previously Untreated Localized Prostate Cancer

2007 ◽  
Vol 178 (6) ◽  
pp. 2366-2371 ◽  
Author(s):  
Michael O. Koch ◽  
Thomas Gardner ◽  
Liang Cheng ◽  
Russell J. Fedewa ◽  
Ralf Seip ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase I ◽  
High Intensity ◽  
Focused Ultrasound ◽  
High Intensity Focused Ultrasound ◽  
Localized Prostate Cancer

scholarly journals First Clinical Experience of Intra-Operative High Intensity Focused Ultrasound in Patients with Colorectal Liver Metastases: A Phase I-IIa Study

PLoS ONE ◽  
2015 ◽  
Vol 10 (2) ◽  
pp. e0118212 ◽  
Author(s):  
Aurélien Dupré ◽  
David Melodelima ◽  
David Pérol ◽  
Yao Chen ◽  
Jérémy Vincenot ◽  
...  
Keyword(s):  
Phase I ◽  
Liver Metastases ◽  
Clinical Experience ◽  
High Intensity ◽  
Colorectal Liver Metastases ◽  
Focused Ultrasound ◽  
High Intensity Focused Ultrasound

scholarly journals Phase I feasibility study of Magnetic Resonance guided High Intensity Focused Ultrasound-induced hyperthermia, Lyso-Thermosensitive Liposomal Doxorubicin and cyclophosphamide in de novo stage IV breast cancer patients: study protocol of the i-GO study

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040162
Author(s):  
Josanne S de Maar ◽  
Britt B M Suelmann ◽  
Manon N G J A Braat ◽  
P J van Diest ◽  
H H B Vaessen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Magnetic Resonance ◽  
Phase I ◽  
High Intensity ◽  
Focused Ultrasound ◽  
Liposomal Doxorubicin ◽  
De Novo ◽  
Stage Iv ◽  
High Intensity Focused Ultrasound ◽  
Induced Hyperthermia

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 analysisThis is a single-arm phase I study in 12 chemotherapy-naïve patients with de novo stage IV HER2-negative breast cancer. Previous endocrine treatment is allowed. Study treatment consists of up to six cycles of LTLD at 21-day intervals, administered during MR-HIFU-induced hyperthermia to the primary tumour. We will aim for 60 min of hyperthermia at 40°C–42°C using a dedicated MR-HIFU breast system (Profound Medical, Mississauga, Canada). Afterwards, intravenous cyclophosphamide will be administered. Primary endpoints are safety, tolerability and feasibility. The secondary endpoint is efficacy, assessed by radiological response.This approach could lead to optimal loco-regional control with less extensive or even no surgery, in de novo stage IV patients and in stage II/III patients allocated to receive neoadjuvant chemotherapy.Ethics and disseminationThis 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 numbersNCT03749850, EudraCT 2015-005582-23.

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