Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC: the RALLY protocol
Abstract Background High dose unilobar radioembolization (also termed ‘radiation lobectomy’)—the transarterial unilobar infusion of radioactive microspheres as a means of controlling tumour growth while concomitantly inducing future liver remnant hypertrophy—has recently gained interest as induction...
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| Format: | Article |
| Language: | English |
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BMC
2023-08-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-023-11280-9 |
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| author | Daan Andel Marnix G. E. H. Lam Joep de Bruijne Maarten L. J. Smits Arthur J. A. T. Braat Adriaan Moelker Erik Vegt Simeon J. S. Ruiter Walter Noordzij Gianluca Grazi Giulio E. Vallati Roel J. Bennink Otto M. van Delden Onno W. Kranenburg Jan N. M. Ijzermans Maarten W. Nijkamp Joris I. Erdmann Rosa Sciuto Jeroen Hagendoorn Inne H. M. Borel Rinkes |
| author_facet | Daan Andel Marnix G. E. H. Lam Joep de Bruijne Maarten L. J. Smits Arthur J. A. T. Braat Adriaan Moelker Erik Vegt Simeon J. S. Ruiter Walter Noordzij Gianluca Grazi Giulio E. Vallati Roel J. Bennink Otto M. van Delden Onno W. Kranenburg Jan N. M. Ijzermans Maarten W. Nijkamp Joris I. Erdmann Rosa Sciuto Jeroen Hagendoorn Inne H. M. Borel Rinkes |
| author_sort | Daan Andel |
| collection | DOAJ |
| description | Abstract Background High dose unilobar radioembolization (also termed ‘radiation lobectomy’)—the transarterial unilobar infusion of radioactive microspheres as a means of controlling tumour growth while concomitantly inducing future liver remnant hypertrophy—has recently gained interest as induction strategy for surgical resection. Prospective studies on the safety and efficacy of the unilobar radioembolization-surgery treatment algorithm are lacking. The RALLY study aims to assess the safety and toxicity profile of holmium-166 unilobar radioembolization in patients with hepatocellular carcinoma ineligible for surgery due to insufficiency of the future liver remnant. Methods The RALLY study is a multicenter, interventional, non-randomized, open-label, non-comparative safety study. Patients with hepatocellular carcinoma who are considered ineligible for surgery due to insufficiency of the future liver remnant (< 2.7%/min/m2 on hepatobiliary iminodiacetic acid scan will be included. A classical 3 + 3 dose escalation model will be used, enrolling three to six patients in each cohort. The primary objective is to determine the maximum tolerated treated non-tumourous liver-absorbed dose (cohorts of 50, 60, 70 and 80 Gy). Secondary objectives are to evaluate dose–response relationships, to establish the safety and feasibility of surgical resection following unilobar radioembolization, to assess quality of life, and to generate a biobank. Discussion This will be the first clinical study to assess the unilobar radioembolization-surgery treatment algorithm and may serve as a stepping stone towards its implementation in routine clinical practice. Trial registration Netherlands Trial Register NL8902 , registered on 2020–09-15. |
| first_indexed | 2024-03-10T17:39:16Z |
| format | Article |
| id | doaj.art-0365f4d63da54b7a86f00d0c8e5c1b7c |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-03-10T17:39:16Z |
| publishDate | 2023-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-0365f4d63da54b7a86f00d0c8e5c1b7c2023-11-20T09:43:53ZengBMCBMC Cancer1471-24072023-08-012311910.1186/s12885-023-11280-9Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC: the RALLY protocolDaan Andel0Marnix G. E. H. Lam1Joep de Bruijne2Maarten L. J. Smits3Arthur J. A. T. Braat4Adriaan Moelker5Erik Vegt6Simeon J. S. Ruiter7Walter Noordzij8Gianluca Grazi9Giulio E. Vallati10Roel J. Bennink11Otto M. van Delden12Onno W. Kranenburg13Jan N. M. Ijzermans14Maarten W. Nijkamp15Joris I. Erdmann16Rosa Sciuto17Jeroen Hagendoorn18Inne H. M. Borel Rinkes19Department of Surgical Oncology, University Medical Center UtrechtDepartment of Radiology and Nuclear Medicine, University Medical Center UtrechtDepartment Gastroenterology and Hepatology, University Medical Center UtrechtDepartment of Radiology and Nuclear Medicine, University Medical Center UtrechtDepartment of Radiology and Nuclear Medicine, University Medical Center UtrechtDepartment of Radiology and Nuclear Medicine, Erasmus MC University Medical CenterDepartment of Radiology and Nuclear Medicine, Erasmus MC University Medical CenterDepartment of HPB & Liver Transplantation, University Medical Center GroningenDepartment of Nuclear Medicine and Molecular Imaging, University Medical Center GroningenHepatopancreatobiliary Surgery, IRCCS - Regina Elena National Cancer InstituteInterventional Radiology, IRCCS - Regina Elena National Cancer InstituteDepartment of Radiology and Nuclear Medicine, Cancer Center, Amsterdam UMC, Location University of AmsterdamDepartment of Radiology and Nuclear Medicine, Cancer Center, Amsterdam UMC, Location University of AmsterdamDepartment of Surgical Oncology, University Medical Center UtrechtDepartment of Surgery, Erasmus MC University Medical CenterDepartment of HPB & Liver Transplantation, University Medical Center GroningenDepartment of Surgery, Cancer Center, Amsterdam UMC, Location Vrije Universiteit AmsterdamNuclear Medicine, IRCCS - Regina Elena National Cancer InstituteDepartment of Surgical Oncology, University Medical Center UtrechtDepartment of Surgical Oncology, University Medical Center UtrechtAbstract Background High dose unilobar radioembolization (also termed ‘radiation lobectomy’)—the transarterial unilobar infusion of radioactive microspheres as a means of controlling tumour growth while concomitantly inducing future liver remnant hypertrophy—has recently gained interest as induction strategy for surgical resection. Prospective studies on the safety and efficacy of the unilobar radioembolization-surgery treatment algorithm are lacking. The RALLY study aims to assess the safety and toxicity profile of holmium-166 unilobar radioembolization in patients with hepatocellular carcinoma ineligible for surgery due to insufficiency of the future liver remnant. Methods The RALLY study is a multicenter, interventional, non-randomized, open-label, non-comparative safety study. Patients with hepatocellular carcinoma who are considered ineligible for surgery due to insufficiency of the future liver remnant (< 2.7%/min/m2 on hepatobiliary iminodiacetic acid scan will be included. A classical 3 + 3 dose escalation model will be used, enrolling three to six patients in each cohort. The primary objective is to determine the maximum tolerated treated non-tumourous liver-absorbed dose (cohorts of 50, 60, 70 and 80 Gy). Secondary objectives are to evaluate dose–response relationships, to establish the safety and feasibility of surgical resection following unilobar radioembolization, to assess quality of life, and to generate a biobank. Discussion This will be the first clinical study to assess the unilobar radioembolization-surgery treatment algorithm and may serve as a stepping stone towards its implementation in routine clinical practice. Trial registration Netherlands Trial Register NL8902 , registered on 2020–09-15.https://doi.org/10.1186/s12885-023-11280-9Radiation lobectomyRadioembolizationHolmium-166166HoHepatocellular carcinomaUnilobar radioembolization |
| spellingShingle | Daan Andel Marnix G. E. H. Lam Joep de Bruijne Maarten L. J. Smits Arthur J. A. T. Braat Adriaan Moelker Erik Vegt Simeon J. S. Ruiter Walter Noordzij Gianluca Grazi Giulio E. Vallati Roel J. Bennink Otto M. van Delden Onno W. Kranenburg Jan N. M. Ijzermans Maarten W. Nijkamp Joris I. Erdmann Rosa Sciuto Jeroen Hagendoorn Inne H. M. Borel Rinkes Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC: the RALLY protocol BMC Cancer Radiation lobectomy Radioembolization Holmium-166 166Ho Hepatocellular carcinoma Unilobar radioembolization |
| title | Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC: the RALLY protocol |
| title_full | Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC: the RALLY protocol |
| title_fullStr | Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC: the RALLY protocol |
| title_full_unstemmed | Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC: the RALLY protocol |
| title_short | Dose finding study for unilobar radioembolization using holmium-166 microspheres to improve resectability in patients with HCC: the RALLY protocol |
| title_sort | dose finding study for unilobar radioembolization using holmium 166 microspheres to improve resectability in patients with hcc the rally protocol |
| topic | Radiation lobectomy Radioembolization Holmium-166 166Ho Hepatocellular carcinoma Unilobar radioembolization |
| url | https://doi.org/10.1186/s12885-023-11280-9 |
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