A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional

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

Currently Recruiting.

Please note that information regarding clinical trials is being rovided for informational purposes only.The Cholangiocarcinoma Foundation does not endorse any specific clinical trial. Please discuss any questions you may have about clinical trials with your healthcare provider.

https://clinicaltrials.gov/ct2/show/NCT03338062

PurposeThe 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 CancerHepatocellular CarcinomaCholangiocarcinoma
Diagnostic Test: Hepatobiliary Iminodiacetic Acid (HIDA) scanDiagnostic 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:

Genetics Home Reference related topics: cholangiocarcinoma
MedlinePlus related topics: Nuclear Scans
Genetic and Rare Diseases Information Center resources: Bile Duct Cancer
U.S. FDA Resources

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 ScanTwo 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) scanHepatobiliary 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 contrastMRI 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

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.

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