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Impact of Y90 Radiation Segmentectomy on HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248375
Recruitment Status : Active, not recruiting
First Posted : August 14, 2017
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Aaron M Fischman, Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Radiation: Radiation Segmentectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Individuals with the targeted medical condition is given the experimental therapy and then followed over time to observe their response.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of 90Yttrium (Y90) Radiation Segmentectomy on Hepatocellular Carcinoma and Cirrhosis
Actual Study Start Date : August 3, 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Radiation Segmentectomy
Radiation Segmentectomy on Resectable HCC
Radiation: Radiation Segmentectomy
The administration of radioactivity in a branch of an artery of the liver




Primary Outcome Measures :
  1. Tumor response according to mRECIST [ Time Frame: 2 years ]

    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 sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions SD = Any cases that do not qualify for either partial response or progressive disease PD = An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started



Secondary Outcome Measures :
  1. Time to Progression (TTP) [ Time Frame: 2 years ]
    The length of time from Radiation Segmentectomy until progression of disease based on mRECIST

  2. Liver Function test [ Time Frame: 2 years ]
    Toxicity resulting from Radiation Segmentectomy with Theraspheres measured by liver function lab values

  3. Number of adverse events [ Time Frame: 2 years ]
    Number of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 18 years, regardless of race or gender
  • Hepatocellular Carcinoma confirmed by histology for non-cirrhotic patients or non-invasive criteria according to AASLD for cirrhotic patients
  • Child-Pugh class A or B7 without ascites
  • Single tumor nodule ≤ 3 cm with a maximum distance of 5 mm from portal vein, hepatic vein, inferior vena cava, diaphragm, heart, stomach, bowel, liver capsule, gallbladder, bile duct
  • No prior locoregional treatment or external beam therapy of current HCC (recurrent HCC after resection may be included)
  • No confirmed extrahepatic metastases
  • No evidence of macrovascular invasion
  • ECOG 0
  • Albumin > 3.0 g/dL
  • PLT ≥ 40 x103/μL
  • WBC ≥ 1.5 x103/μL
  • AST/ALT ≤ 5 times the upper limit of normal (U/L)
  • Creatinine ≤ 2.0 mg /dL
  • No indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation)
  • No contraindication to angiography or selective visceral catheterization
  • No history of severe allergy or intolerance to contrast agents, narcotics, sedatives.
  • Negative serum pregnancy test
  • Signed informed consent form

Exclusion Criteria:

  • Not meeting the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248375


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Aaron Fischman, MD Icahn School of Medicine at Mount Sinai
Publications:

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Responsible Party: Aaron M Fischman, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03248375    
Other Study ID Numbers: GCO 15-0980
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Aaron M Fischman, Icahn School of Medicine at Mount Sinai:
Unresectable Hepatocellular Carcinoma
Radioembolization
Radiation Segmentectomy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases