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

NCT03338062 | Completed Results DMC FDA Device

• 1 other identifier: IUSCC-0604
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Radiation Treatment

Outcome Measures

Primary Outcomes (1)

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

  The functional reserve of the liver for both standard SBRT planning and theragnostic SBRT planning will be calculated for each patient regardless of which plan was ultimately chosen. Function reserve of the liver = (number of counts outside 15 Gy isodose line / total number of counts within the liver) \* global liver function; where global liver function is the rate of liver uptake (%/min) between 150 to 300 seconds normalized to body surface area (m\^2) using the Du Bois method. The difference in functional reserve between the theragnostic plan and the standard plan was calculated for each patient.

  Day -1 of Radiation Treatment

Secondary Outcomes (9)

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

  Day -1 of Radiation Treatment

• Duration of Local Control

  Up to 15 months

• Progression Free Survival

  Up to 15 months

• Overall Survival

  Up to 3 years

• Time to Transplant

  Up to 15 months

Study Arms (2)

Theragnostic SBRT Planning

EXPERIMENTAL

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.

Diagnostic Test: Hepatobiliary Iminodiacetic Acid (HIDA) scan

Standard SBRT Planning

NO INTERVENTION

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.

Interventions

Hepatobiliary Iminodiacetic Acid (HIDA) scan DIAGNOSTIC_TEST

HIDA scan was used as the planning scan for SBRT.

Theragnostic SBRT Planning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• History of liver resection (at any time)
• History of cirrhosis (any cause), fatty liver disease, or hepatic insufficiency due to any cause
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular; Cholangiocarcinoma

Interventions

Radionuclide Imaging

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: Dr. Ryan Rhome
• Organization: IndianaU

rrhome@iu.edu

(317) 944-1367

Study Officials

• Ryan M Rhome, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor- Department of Radiation Oncology

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 9, 2017
• Study Start: June 13, 2017
• Primary Completion: September 2, 2019
• Study Completion: September 2, 2019
• Last Updated: February 26, 2021
• Results First Posted: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)