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

NCT ID: NCT03338062

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-13
• Study Completion Date: 2019-09-02

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.

Conditions

Liver Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Theragnostic SBRT Planning

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.

Group Type: EXPERIMENTAL

Hepatobiliary Iminodiacetic Acid (HIDA) scan

Intervention Type: DIAGNOSTIC_TEST

HIDA scan was used as the planning scan for SBRT.

Standard SBRT Planning

The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hepatobiliary Iminodiacetic Acid (HIDA) scan

HIDA scan was used as the planning scan for SBRT.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Ryan Rhome,

Assistant Professor- Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan M Rhome, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IUSCC-0604

Identifier Type: -

Identifier Source: org_study_id