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The aim of this pilot study is to assess the efficacy of radiation segmentectomy with Theraspheres in patients with unresectable hepatocellular carcinoma that would qualify for thermal ablation as per the BCLC guidelines, but are unable to receive thermal ablation due to unfavorable location of target lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Segmentectomy | Other | Radiation Segmentectomy on Resectable HCC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Segmentectomy | Radiation | The administration of radioactivity in a branch of an artery of the liver |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Local Tumor Response According to mRECIST | Efficacy of 90Yttrium (Y90) Radiation Segmentectomy on Unresectable Hepatocellular Carcinoma as measured by tumor response according to mRECIST. CR = Disappearance of any intratumoral arterial enhancement in all target lesions PR = At least a 30% decrease in the diameter of the viable (enhancement in the arterial phase) target lesion SD = Any cases that do not qualify for either partial response or progressive disease PD = An increase of at least 20% in the diameter of viable (enhancing) target lesion | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Progression (TTP) | Time until progression of the target lesion and overall disease based on mRECIST | 2 years |
| Cumulative Incidence of Participants With Local Progression | Cumulative incidence function estimation of the incidence of the occurrence of local progression (event) at 1 year and 2 years while taking the competing risk of transplant into account. Local progression was defined per modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) for target lesions and assessed by MRI with local progression defined as an >20% increase in the diameter of the viable (enhancing) target lesion, taking as a reference of the baseline enhancing tumor size. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Fischman, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11029989 | Background | Wong JB, McQuillan GM, McHutchison JG, Poynard T. Estimating future hepatitis C morbidity, mortality, and costs in the United States. Am J Public Health. 2000 Oct;90(10):1562-9. doi: 10.2105/ajph.90.10.1562. | |
| 11391528 | Background | Yao FY, Ferrell L, Bass NM, Watson JJ, Bacchetti P, Venook A, Ascher NL, Roberts JP. Liver transplantation for hepatocellular carcinoma: expansion of the tumor size limits does not adversely impact survival. Hepatology. 2001 Jun;33(6):1394-403. doi: 10.1053/jhep.2001.24563. |
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Individuals were enrolled between Aug 3, 2016, and April 4, 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Segmentectomy | Patients diagnosed with hepatocellular carcinoma underwent radiation segmentectomy on resectable hepatocellular carcinoma and cirrhosis HCC. Radiation segmentectomy was done with ⁹⁰Y microspheres infused through selective branches off the hepatic artery. The delivery device used was glass-based (TheraSphere; Boston Scientific, Ottawa, ON, Canada), in which ⁹⁰Y is an integral constituent of the biocompatible glass matrix. Estimated dose to the treated area was >205Gy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Segmentectomy | Radiation Segmentectomy on Resectable HCC on patients diagnosed with hepatocellular carcinoma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Local Tumor Response According to mRECIST | Efficacy of 90Yttrium (Y90) Radiation Segmentectomy on Unresectable Hepatocellular Carcinoma as measured by tumor response according to mRECIST. CR = Disappearance of any intratumoral arterial enhancement in all target lesions PR = At least a 30% decrease in the diameter of the viable (enhancement in the arterial phase) target lesion SD = Any cases that do not qualify for either partial response or progressive disease PD = An increase of at least 20% in the diameter of viable (enhancing) target lesion | Posted | Count of Participants | Participants | 2 years |
|
up to 2 years and every 3 months since treatment for 24 months for laboratory changes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiation Segmentectomy | Radiation Segmentectomy on Resectable HCC on patients diagnosed with hepatocellular carcinoma |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial Injury | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Edward Kim | Icahn School of Medicine at Mount Sinai | (212) 241-7409 | Edward.Kim@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2017 | Jul 29, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Individuals with the targeted medical condition is given the experimental therapy and then followed over time to observe their response.
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| 1 year and 2 years |
| Quantifying Dose to Target Lesion | The dose was calculated using PET/CT calculated dose estimation delivered to the tumor. Counts on PET/CT post-treatment were used to estimate the dose delivered to the tumor. | 0 days |
| Number of Treatment-related Adverse Events | Number of treatment related adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 5.0 (CTCAE). | For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory and clinical symptoms |
| Number of Participants With Access Site-related Adverse Events | Number of participants with access site-related adverse events | For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory and clinical symptoms |
| Number of Participants With Treatment-related Laboratory Adverse Events | Number of participants with treatment-related laboratory adverse events assessed 6 weeks post-treatment then every 3 months since treatment for 24 months | For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory changes |
| 11772979 | Background | Llovet JM, Mas X, Aponte JJ, Fuster J, Navasa M, Christensen E, Rodes J, Bruix J. Cost effectiveness of adjuvant therapy for hepatocellular carcinoma during the waiting list for liver transplantation. Gut. 2002 Jan;50(1):123-8. doi: 10.1136/gut.50.1.123. |
| 12540794 | Background | Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047. |
| 10973388 | Background | Curley SA, Izzo F, Ellis LM, Nicolas Vauthey J, Vallone P. Radiofrequency ablation of hepatocellular cancer in 110 patients with cirrhosis. Ann Surg. 2000 Sep;232(3):381-91. doi: 10.1097/00000658-200009000-00010. |
| 15590181 | Background | Cheng JC, Wu JK, Lee PC, Liu HS, Jian JJ, Lin YM, Sung JL, Jan GJ. Biologic susceptibility of hepatocellular carcinoma patients treated with radiotherapy to radiation-induced liver disease. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1502-9. doi: 10.1016/j.ijrobp.2004.05.048. |
| 16183482 | Background | Dawson LA, Ten Haken RK. Partial volume tolerance of the liver to radiation. Semin Radiat Oncol. 2005 Oct;15(4):279-83. doi: 10.1016/j.semradonc.2005.04.005. |
| 19357924 | Background | Gaba RC, Lewandowski RJ, Kulik LM, Riaz A, Ibrahim SM, Mulcahy MF, Ryu RK, Sato KT, Gates V, Abecassis MM, Omary RA, Baker TB, Salem R. Radiation lobectomy: preliminary findings of hepatic volumetric response to lobar yttrium-90 radioembolization. Ann Surg Oncol. 2009 Jun;16(6):1587-96. doi: 10.1245/s10434-009-0454-0. Epub 2009 Apr 9. |
| 18003987 | Background | Young JY, Rhee TK, Atassi B, Gates VL, Kulik L, Mulcahy MF, Larson AC, Ryu RK, Sato KT, Lewandowski RJ, Omary RA, Salem R. Radiation dose limits and liver toxicities resulting from multiple yttrium-90 radioembolization treatments for hepatocellular carcinoma. J Vasc Interv Radiol. 2007 Nov;18(11):1375-82. doi: 10.1016/j.jvir.2007.07.016. |
| 19640737 | Background | Riaz A, Lewandowski RJ, Kulik LM, Mulcahy MF, Sato KT, Ryu RK, Omary RA, Salem R. Complications following radioembolization with yttrium-90 microspheres: a comprehensive literature review. J Vasc Interv Radiol. 2009 Sep;20(9):1121-30; quiz 1131. doi: 10.1016/j.jvir.2009.05.030. Epub 2009 Jul 29. |
| 20175033 | Background | Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19. |
| 20421150 | Background | Riaz A, Gates VL, Atassi B, Lewandowski RJ, Mulcahy MF, Ryu RK, Sato KT, Baker T, Kulik L, Gupta R, Abecassis M, Benson AB 3rd, Omary R, Millender L, Kennedy A, Salem R. Radiation segmentectomy: a novel approach to increase safety and efficacy of radioembolization. Int J Radiat Oncol Biol Phys. 2011 Jan 1;79(1):163-71. doi: 10.1016/j.ijrobp.2009.10.062. Epub 2010 Apr 24. |
| 23332890 | Background | Bargellini I, Bozzi E, Campani D, Carrai P, De Simone P, Pollina L, Cioni R, Filipponi F, Bartolozzi C. Modified RECIST to assess tumor response after transarterial chemoembolization of hepatocellular carcinoma: CT-pathologic correlation in 178 liver explants. Eur J Radiol. 2013 May;82(5):e212-8. doi: 10.1016/j.ejrad.2012.12.009. Epub 2013 Jan 15. |
| 12599233 | Background | Komorizono Y, Oketani M, Sako K, Yamasaki N, Shibatou T, Maeda M, Kohara K, Shigenobu S, Ishibashi K, Arima T. Risk factors for local recurrence of small hepatocellular carcinoma tumors after a single session, single application of percutaneous radiofrequency ablation. Cancer. 2003 Mar 1;97(5):1253-62. doi: 10.1002/cncr.11168. |
| 23428355 | Background | Golfieri R, Renzulli M, Mosconi C, Forlani L, Giampalma E, Piscaglia F, Trevisani F, Bolondi L; Bologna Liver Oncology Group (BLOG). Hepatocellular carcinoma responding to superselective transarterial chemoembolization: an issue of nodule dimension? J Vasc Interv Radiol. 2013 Apr;24(4):509-17. doi: 10.1016/j.jvir.2012.12.013. Epub 2013 Feb 18. |
| 35617978 | Derived | Kim E, Sher A, Abboud G, Schwartz M, Facciuto M, Tabrizian P, Knesaurek K, Fischman A, Patel R, Nowakowski S, Llovet J, Taouli B, Lookstein R. Radiation segmentectomy for curative intent of unresectable very early to early stage hepatocellular carcinoma (RASER): a single-centre, single-arm study. Lancet Gastroenterol Hepatol. 2022 Sep;7(9):843-850. doi: 10.1016/S2468-1253(22)00091-7. Epub 2022 May 23. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Cause of liver disease | there could be more than one reported cause of liver disease for each participant | Count of Participants | Participants |
|
| Child-Pugh score | Total score from 5-15, categorized into Child-Pugh grades A (5 to 6 points), B (7 to 9 points), or C (10 to 15 points). Higher score indicates poorer health outcomes. | Count of Participants | Participants |
|
| α-Fetoprotein | Alpha fetoprotein (AFP) is a protein produced by the liver and yolk sac of a developing baby during pregnancy. The normal values in males or nonpregnant females is generally less than 40 micrograms/liter. | Median | Full Range | ng/mL |
|
| Albumin-bilirubin grade (ALBI) | ALBI score =0.66×log10 [total bilirubin (µmol/L)] - 0.085× [albumin (g/L)]. grade 1 (score ≤-2.60) grade 2 (-2.60< score ≤-1.39) and grade 3 (score >-1.39) Lower grade represents better health outcomes. | Count of Participants | Participants |
|
| Ascites | Count of Participants | Participants |
|
| Tumor diameter | Mean | Standard Deviation | cm |
|
| Liver segment tumor distribution | Measure refers to the liver segments (1-8 based on Couinaud classification) of tumor location based on pre-treatment imaging | Count of Participants | Participants |
|
| Location | Central or peripheral location of tumors determined based on pretreatment imaging | Count of Participants | Participants |
|
| Number of injection locations | Count of Participants | Participants |
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| Lobar volume | Median | Full Range | mL |
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| Perfused liver volume | Mean | Standard Deviation | mL |
|
| Distribution of Perfused Liver Volumes | Number of patients with perfused liver volumes <100cc, 100-200 cc, and >200cc measured using cone beam CT (CBCT) | Count of Participants | Participants |
|
| Lung shunt fraction (LSF) | The lung shunt fraction is calculated using macroaggregated albumin (MAA) and performing a nuclear medicine study. It represents the percentage determined by the ratio of the counts in the lungs to the summed counts in the lungs and liver. | Mean | Full Range | percentage reaching lung |
|
| Calculated dose to the perfused segment | The calculated dose was calculated as a segmental delivery with the goal of more than 205 Gy to the perfused area using the Committee on Medical Internal Radiation Dose model based on tumour response and survival data. | Median | Full Range | Gy |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Median Time to Progression (TTP) | Time until progression of the target lesion and overall disease based on mRECIST | Data for participants who had target lesion progression only | Posted | Median | 95% Confidence Interval | days | 2 years |
|
|
|
| Secondary | Cumulative Incidence of Participants With Local Progression | Cumulative incidence function estimation of the incidence of the occurrence of local progression (event) at 1 year and 2 years while taking the competing risk of transplant into account. Local progression was defined per modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) for target lesions and assessed by MRI with local progression defined as an >20% increase in the diameter of the viable (enhancing) target lesion, taking as a reference of the baseline enhancing tumor size. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year and 2 years |
|
|
|
| Secondary | Quantifying Dose to Target Lesion | The dose was calculated using PET/CT calculated dose estimation delivered to the tumor. Counts on PET/CT post-treatment were used to estimate the dose delivered to the tumor. | Dose delivered to the tumour was calculated for 26 (90%) patients with 90Y PET CT imaging. Three (7%) patients were excluded due to technical issues. | Posted | Median | 95% Confidence Interval | Gy | 0 days |
|
|
|
| Secondary | Number of Treatment-related Adverse Events | Number of treatment related adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 5.0 (CTCAE). | Posted | Number | events | For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory and clinical symptoms |
|
|
|
| Secondary | Number of Participants With Access Site-related Adverse Events | Number of participants with access site-related adverse events | Posted | Count of Participants | Participants | For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory and clinical symptoms |
|
|
|
| Secondary | Number of Participants With Treatment-related Laboratory Adverse Events | Number of participants with treatment-related laboratory adverse events assessed 6 weeks post-treatment then every 3 months since treatment for 24 months | All Patients | Posted | Count of Participants | Participants | For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory changes |
|
|
|
| 1 |
| 29 |
| 0 |
| 29 |
| 26 |
| 29 |
| Haemotoma | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment | Treatment-related |
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| Nausea, Vomiting, or Anorexia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Treatment-related |
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| Abdominal discomfort | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Treatment-related |
|
| Ascites | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Treatment-related |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment | Treatment-related laboratory adverse events |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment | Treatment-related laboratory adverse events |
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| Anaemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment | Treatment-related laboratory adverse events |
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| AST or ALT increased | Hepatobiliary disorders | CTCAE (5.0) | Systematic Assessment | Treatment-related laboratory adverse events |
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| ALP increased | Hepatobiliary disorders | CTCAE (5.0) | Systematic Assessment | Treatment-related laboratory adverse events |
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| Total blood bilirubin increased | Hepatobiliary disorders | CTCAE (5.0) | Systematic Assessment | Treatment-related laboratory adverse events |
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| Albumin decreased | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment | Treatment-related laboratory adverse events |
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| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment | Treatment-related laboratory adverse events |
|
| International normalised ratio increased | Investigations | CTCAE (5.0) | Systematic Assessment | Treatment-related laboratory adverse events |
|
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| Title | Measurements |
|---|
|
| ascites |
|
| laboratory changes |
|
| Title | Measurements |
|---|---|
|
| AST or ALT increased |
|
| ALP increased |
|
| Total blood bilirubin increased |
|
| Albumin decreased |
|
| Creatinine increased |
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| International normalised ratio increased |
|