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A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy

This study is currently recruiting participants.
Verified November 2017 by Susannah Ellsworth, Indiana University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03338062
First Posted: November 9, 2017
Last Update Posted: November 9, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Susannah Ellsworth, Indiana University
  Purpose
The purpose of this study is to compare radiation treatment plans that are designed for patients with liver cancer. One treatment plan will be created using routine procedures and scans normally performed for radiation treatment planning. The other treatment plan will be created using routine procedures with the addition of two imaging scans; a HIDA (Hepatobiliary Iminodiacetic Acid) scan and an MRI (Magnetic Resonance Imaging) scan. This study will evaluate if adding these imaging scans to treatment planning can reduce the amount of radiation to healthy liver tissue during treatment.

Condition Intervention
Liver Cancer Hepatocellular Carcinoma Cholangiocarcinoma Diagnostic Test: Hepatobiliary Iminodiacetic Acid (HIDA) scan Diagnostic Test: MRI with Eovist contrast

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Susannah Ellsworth, Indiana University:

Primary Outcome Measures:
  • Functional reserve of Liver [ Time Frame: Day -1 of Radiation Treatment ]
    The functional reserve will be calculated by (number of counts outside 15 Gy isodose line / total number of counts within the liver) * global liver function.


Secondary Outcome Measures:
  • Rate that theragnostically planned radiation is chosen for the radiation treatment plan [ Time Frame: Day -1 of Radiation Treatment ]
    The rate at which the plan that utilized the HIDA scan is chosen for the actual treatment will be summarized along with the corresponding exact 95% Binomial confidence interval.

  • Local Control [ Time Frame: 12 months ]
    Local control will be evaluated using RECIST 1.1 criteria.

  • Progression Free Survival [ Time Frame: 12 months ]
  • Overall Survival [ Time Frame: 12 months ]
  • Time to transplant [ Time Frame: 12 months ]
  • Distant liver failure [ Time Frame: 12 months ]
  • Time until Salvage treatment [ Time Frame: 12 months ]
  • Treatment toxicity [ Time Frame: 12 months ]
    The rate of decline of CTP class as well as the rate of any grade of hepatic toxicities will be collected and graded based on CTCAE

  • Liver volume changes in treated and untreated liver [ Time Frame: 12 months ]

Estimated Enrollment: 18
Actual Study Start Date: June 13, 2017
Estimated Study Completion Date: December 1, 2020
Estimated Primary Completion Date: December 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIDA and MRI Scan
Two imaging scans will be added to the standard radiation planning, treatment and follow up process; a Hepatobiliary Iminodiacetic Acid (HIDA) scan and an MRI scan with Eovist contrast
Diagnostic Test: Hepatobiliary Iminodiacetic Acid (HIDA) scan
Hepatobiliary Iminodiacetic Acid (HIDA) scan will be performed for radiation treatment planning, midway through radiation treatment, and at 3, 6 and 12 months after completion of radiation treatment in addition to standard of care imaging.
Diagnostic Test: MRI with Eovist contrast
MRI with Eovist contrast will be performed for radiation treatment planning, midway through radiation treatment, and at 3, 6 and 12 months after completion of radiation treatment in addition to standard of care imaging.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Primary liver malignancy including hepatocellular carcinoma (HCC) or cholangiocarcinoma
  • Subjects must have a Child-Turcotte-Pugh (CTP) score ≤ 7 to be eligible

Exclusion Criteria:

  • Subjects who are pregnant or planning to become pregnant during the study.
  • No more than 3 lesions can be treated. Total diameter of all lesions must be less than or equal to 6 cm
  • Prior radiation treatment to the upper abdomen
  • Active infection, active upper GI ulceration or hemorrhage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
  Contacts and Locations
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): NCT03338062


Contacts
Contact: Jill Deluca 317-944-2524 jdelucca@iupui.edu

Locations
United States, Indiana
Indiana University Melvin & Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jill Deluca    317-944-2524    jdelucca@iupui.edu   
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Susannah G Ellsworth, MD Indiana University School of Medicine
  More Information

Responsible Party: Susannah Ellsworth, Assistant Professor of Clinical Radiation Oncology, Indiana University
ClinicalTrials.gov Identifier: NCT03338062     History of Changes
Other Study ID Numbers: IUSCC-0604
First Submitted: November 7, 2017
First Posted: November 9, 2017
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Susannah Ellsworth, Indiana University:
Radiation Treatment

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Carcinoma, Hepatocellular
Liver Neoplasms
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Iminodiacetic acid
Chelating Agents
Sequestering Agents