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Impact of Y90 Radiation Segmentectomy on HCC

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiation Segmentectomy
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Unresectable Hepatocellular Carcinoma, Radioembolization, Radiation Segmentectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Radiation Segmentectomy

Arm Description

Radiation Segmentectomy on Resectable HCC

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Median Time to Progression (TTP)
Time until progression of the target lesion and overall disease based on mRECIST
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.
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.
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).
Number of Participants With Access Site-related Adverse Events
Number of participants with access site-related adverse events
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

Full Information

First Posted
August 10, 2017
Last Updated
January 18, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT03248375
Brief Title
Impact of Y90 Radiation Segmentectomy on HCC
Official Title
The Impact of 90Yttrium (Y90) Radiation Segmentectomy on Hepatocellular Carcinoma and Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 3, 2016 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Unresectable Hepatocellular Carcinoma, Radioembolization, Radiation Segmentectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation Segmentectomy
Arm Type
Other
Arm Description
Radiation Segmentectomy on Resectable HCC
Intervention Type
Radiation
Intervention Name(s)
Radiation Segmentectomy
Intervention Description
The administration of radioactivity in a branch of an artery of the liver
Primary Outcome Measure Information:
Title
Number of Participants With Local Tumor Response According to mRECIST
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Median Time to Progression (TTP)
Description
Time until progression of the target lesion and overall disease based on mRECIST
Time Frame
2 years
Title
Cumulative Incidence of Participants With Local Progression
Description
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.
Time Frame
1 year and 2 years
Title
Quantifying Dose to Target Lesion
Description
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.
Time Frame
0 days
Title
Number of Treatment-related Adverse Events
Description
Number of treatment related adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 5.0 (CTCAE).
Time Frame
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
Title
Number of Participants With Access Site-related Adverse Events
Description
Number of participants with access site-related adverse events
Time Frame
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
Title
Number of Participants With Treatment-related Laboratory Adverse Events
Description
Number of participants with treatment-related laboratory adverse events assessed 6 weeks post-treatment then every 3 months since treatment for 24 months
Time Frame
For 2 years with visits 6 weeks post treatment then every 3 months since treatment for 24 months for assessment of laboratory changes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Fischman, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Impact of Y90 Radiation Segmentectomy on HCC

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