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

Brief Title

A Pilot Study to Assess Theragnostically Planned Liver Radiation to Optimize Radiation Therapy

Official Title

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

Brief Summary

      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.
    

Study Type

Interventional

Primary Outcome

Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning

Secondary Outcome

 Percentage of Participants for Whom Theragnostically Planned Radiation is Chosen for the Radiation Treatment Plan

Condition

Liver Cancer

Intervention

Hepatobiliary Iminodiacetic Acid (HIDA) scan

Study Arms / Comparison Groups

 Theragnostic SBRT Planning

Description:  The theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Diagnostic Test

Estimated Enrollment

15

Start Date

June 13, 2017

Completion Date

September 2, 2019

Primary Completion Date

September 2, 2019

Eligibility Criteria

        Inclusion Criteria

          -  Subjects must be ≥ 18 years of age at the time of signing informed consent

          -  Diagnosis of primary liver malignancy (including hepatocellular carcinoma [HCC] or
             cholangiocarcinoma) or liver metastasis from any primary solid tumor site by
             characteristic imaging findings on CT or MRI, clinical presentation, and/or pathologic
             confirmation of diagnosis.

          -  Subjects with other current or prior malignancies are eligible for this study.

          -  Patients with liver metastases must have at least one of the following clinical
             factors that may affect liver function:

               1. History of liver resection (at any time)

               2. History of cirrhosis (any cause), fatty liver disease, or hepatic insufficiency
                  due to any cause

               3. Prior radiation to the upper abdomen including radioembolization

          -  ECOG (Zubrod) Performance Status 0-2.

          -  Subjects must have a Child-Turcotte-Pugh (CTP) score ≤ 7 to be eligible.

          -  Patients who have been previously treated with non-SBRT liver directed therapies may
             be enrolled on study. At least 3 months must have elapsed between the most recent
             liver-directed therapy and study entry.

          -  Ability to provide written informed consent and HIPAA authorization

          -  Subjects with an allergy to contrast agents may be enrolled at the treating
             physician's discretion with appropriate pre-treatment and symptom management.

        Exclusion Criteria

          -  Subjects who are pregnant or planning to become pregnant during the study. Women of
             child bearing potential must have a negative pregnancy test

          -  Subjects must not have received chemotherapy within 2 weeks of planned 1st day of RT.

          -  No more than 3 lesions may be treated. The maximum sum of the diameter(s) of the
             lesion(s) must be ≤6 cm

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection (or infections requiring systemic antibiotic treatment), active upper GI
             ulceration or hemorrhage, symptomatic congestive heart failure, unstable angina
             pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would in
             the opinion of the investigator limit compliance with study requirements
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ryan M Rhome, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT03338062

Organization ID

IUSCC-0604

Responsible Party

Principal Investigator

Study Sponsor

Indiana University

Study Sponsor

Ryan M Rhome, MD, Principal Investigator, Indiana University School of Medicine

Verification Date

February 2021