Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Correlation Between CT Perfusion and Post Y-90 TARE PET/CT Dosimetry

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: NCT02558205
Recruitment Status : Withdrawn (unable to rectuir)
First Posted : September 23, 2015
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Swim Across America
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:

The purpose of this study is to see if it is possible to establish a relationship between the blood flow and blood volume of liver tumors from CT body perfusion and the radiation dose deposited in the tumors from the radioembolization treatment as measured by PET/CT.

The study will do this by:

  1. Measuring the blood flow and blood volume of tumors in the imaging data from a CT body perfusion
  2. Measuring the radioactivity in the tumors after the radioembolization treatment using PET/CT and then calculating the dose deposited in the tumor
  3. Using statistical analysis to assess the relationship between the dose and the perfusion parameters

In addition, the research may help develop a method for calculating the dose of radioembolization to be delivered to a liver tumor(s) using blood volume and blood flow data obtained from the CT body perfusion scans.


Condition or disease Intervention/treatment
Hepatocellular Carcinoma Radiation: CT Liver Perfusion Radiation: PET/CT of liver

Detailed Description:

The overreaching goal of this line of research is to establish a methodology to produce patient and tumor specific treatment planning for Yttrium-90 radioembolization of hepatocellular carcinoma (HCC). The proposed project will facilitate the collection of preliminary data to support a larger study to more fully establish the relationship between tumor perfusion parameters and delivered radiation dose. Y-90 radioembolization delivers millions of small resin or glass beads attached to or containing (depending on the product) the beta emitting radioisotope of Yttrium. These beads are injected into the patient's hepatic artery during an interventional radiology procedure. The beads are pushed into the hepatic vasculature system by pulsatile flow and eventually become lodged, due to their finite size, in the microvasculature of the liver and tumor and deliver the radiation dose from the high energy beta particles (average energy 0.94 MeV) released during the radioactive decay (half life of 64 hours) in a highly local (~2.5 mm range) manner. The beads are permanently embedded in the vasculature and the radioactivity eventually decays to background.

Current practice is to calculate and deliver an average liver lobe radiation dose based on either the lobar volume or the patient's body surface area. However, because of the hypervascular nature of HCC lesions, the tumors receive a greater proportion of the beads than the healthy liver parenchyma and hence are assumed to receive radiation doses well above that of calculated average liver dose and the dose to the normal liver. Due to the differing vascularity and characteristics of tumors and patients, each Y-90 treatment does not deliver the same dose to the tumor. A less vascular tumor may receive substantially less radiation than a more vascular one which affects the tumoricidal efficacy of the treatment and ultimately the patient's final outcome. New techniques using Positron Emission Tomography (PET)/CT following Y-90 treatment allow for retrospective dosimetry to determine the actual dose delivered to the tumor. However, no methodology exists to plan the dose to be delivered to the tumor prior to the treatment.

This research aims to collect preliminary data to begin to establish a prospective method to use Computed Tomography (CT) perfusion studies of the liver to calculate the expected dose to the HCC lesions and the normal liver based on the blood flow and blood volume. This goal will be achieved by prospectively collecting CT Perfusion studies prior to Y-90 radioembolization treatments and PET/CT immediately following treatments. The relationship between the perfusion parameters representing the vascularity of the lesions and the normal liver and the post treatment PET/CT dosimetry will be established by this line of research. The hypothesized correlation between the perfusion parameters and the tumor dose as established by PET/CT will allow for patient and tumor specific treatment planning ensuring that the appropriate tumoricidal radiation dose is reliably delivered.

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishing a Correlation Between Pre-treatment CT Perfusion Parameter Values and Post-treatment PET/CT Dosimetry to Aid in Tumor-specific Y-90 Radioembolization Treatment Planning for Hepatocellular Carcinoma
Estimated Study Start Date : July 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Group/Cohort Intervention/treatment
CT Perfusion and PET/CT
Patients undergo both a CT liver perfusion study pre Y-90 treatment and a PET/CT of liver following Y-90 treatment. For the PET/CT no additional radioactivity is required.
Radiation: CT Liver Perfusion
Imaging study of liver using injection of Iodine contrast agent done using CT imaging

Radiation: PET/CT of liver
PET/CT of liver following Y-90 treatment. PET/CT imaging uses positron decay of Y-90 to detect distribution of Y-90 in the liver.




Primary Outcome Measures :
  1. Correlation of CT perfusion metrics to radiation dose deposition of Y-90 as measured by PET/CT [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Correlation between CT perfusion metrics and post treatment response as measured by RECIST 1.0 criteria [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients identified for Y-90 transarterial radioembolization of liver tumors with hepatocellular carcinoma
Criteria

Inclusion Criteria:

  • Hepatocellular Carcinoma diagnosis
  • Candidate for Trans-Arterial Radioembolization treatment

Exclusion Criteria:

  • Less than 18 years old
  • Pregnant
  • Iodinated Contrast Agent Allergy

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): NCT02558205


Locations
Layout table for location information
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Swim Across America
Investigators
Layout table for investigator information
Principal Investigator: Mark P Supanich, Ph.D. Rush University Medical Center
Publications:

Layout table for additonal information
Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02558205    
Other Study ID Numbers: 14100902
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Liver Extracts
Hematinics