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Trial record 29 of 44 for:    Gadoxetate

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338062
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Susannah Ellsworth, Indiana University

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.

Condition or disease Intervention/treatment Phase
Liver Cancer Hepatocellular Carcinoma Cholangiocarcinoma Diagnostic Test: Hepatobiliary Iminodiacetic Acid (HIDA) scan Diagnostic Test: MRI with Eovist contrast Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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
Actual Study Start Date : June 13, 2017
Actual Primary Completion Date : September 2, 2019
Actual Study Completion Date : September 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 :
  1. 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.

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

  3. Progression Free Survival [ Time Frame: 12 months ]
  4. Overall Survival [ Time Frame: 12 months ]
  5. Time to transplant [ Time Frame: 12 months ]
  6. Distant liver failure [ Time Frame: 12 months ]
  7. Time until Salvage treatment [ Time Frame: 12 months ]
  8. 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

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


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

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


Locations
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United States, Indiana
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Susannah G Ellsworth, MD Indiana University School of Medicine

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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 Posted: November 9, 2017    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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