Skip to main content
OpenTrials
Completed

NCT Number: NCT02683200

MRI-Guided Stereotactic Body Radiation Therapy in Treating Patients With Liver Metastases or Liver Cancer

This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Combining MRI with SBRT may help doctors to highlight the tissues surrounding the tumor better.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

About this study

PRIMARY OBJECTIVES:

I. To assess the feasibility of utilizing an MRI-guided tri-60Co teletherapy system for liver SBRT, as determined the treating radiation oncologist's ability to accurately visualize and align to the target lesion(s).

II. To assess the feasibility of using a three versus five fraction scheme, for one versus multiple (i.e., =< 5) target lesions.

SECONDARY OBJECTIVES:

I. To determine the tumor local control (LC), disease specific survival (DSS), and overall survival (OS).

II. To gather biomarkers that may elucidate differential immunogenic responses from the three versus the five fraction SBRT regimens.

OUTLINE:

Patients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks.

After completion of study treatment, patients are followed up at approximately 4-6 weeks, and then every 3 months for 2 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients may have either metastatic lesions from another primary site or primary hepatocellular carcinoma; patients with one histologically confirmed metastatic lesion of the liver who are presenting for local therapy for lesions concerning for metastases that cannot or should not be biopsied will also be considered for enrollment on a case by case basis; patients can simultaneously receive treatment for multiple hepatic lesions meeting the prior two requirements, at the discretion of the treating radiation oncologist
  • Karnofsky performance status (KPS) >= 70
  • No active infections requiring systemic antibiotics
  • If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study
  • Ability to understand and willingness to sign a written informed consent

Exclusion criteria

  • Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study
  • Refusal to sign the informed consent
  • Patients who are participating in a concurrent treatment protocol
  • Patients for whom a plan meeting institutional quality criteria cannot be designed for SBRT treatment via the MRI-guided teletherapy unit, but for whom an SBRT plan meeting institutional quality criteria can be designed for a conventional linear accelerator

Treatment and study plan

Image-Guided Adaptive Radiation Therapy

Radiation

Undergo MRI-guided Tri-60Co teletherapy SBRT

Other names: IGART

Stereotactic Body Radiation Therapy

Radiation

Undergo MRI-guided Tri-60Co teletherapy SBRT

Other names: SBRT

Primary outcomes

  1. Plan quality of the MRI guided radiotherapy vs. conventional linac radiotherapy.

    Time frame: Up to 2 years

    Comparing the plan quality of the MRI guided radiotherapy to conventional determined by the ability to create treatment plans that are comparable to those generated by a conventional linear accelerator, and by the treating radiation oncologist's ability to accurately visualize and align to the target lesion

  2. Feasibility of SBRT delivery by the MRI-guided tri-60Co teletherapy system, calculated by recording the number of patients for whom plans were or were not comparable between the two modalities

    Time frame: Up to 2 years

  3. Magnitude of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system

    Time frame: Up to 2 years

  4. Velocity of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system

    Time frame: Up to 2 years

  5. Quality of real-time image guidance provided the tri-60Co system, as defined by the treating radiation oncologist's ability to visualize the target lesion using the on-board MRI

    Time frame: Up to 2 tears

Secondary outcomes

  1. Collection of biomarkers that may be associated with an immunologic systemic response to SBRT

    Time frame: Up to 2 years

  2. DSS

    Time frame: Up to 2 years

  3. Frequency of acute grade 2-5 gastrointestinal toxicity graded using the Common Toxicity Criteria version 4.0

    Time frame: Up to 2 years

  4. Infield tumor LC

    Time frame: Up to 2 years

  5. OS

    Time frame: Up to 2 years

  6. Validity of automatically segmented contours generated by the MRI-guided tri-60Co teletherapy system through independent evaluation of images obtained

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Stereotactic Body Radiotherapy for Liver Metastases and Hepatocellular Carcinoma Utilizing an MRI-Guided Tri-60Co Teletherapy System

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2016
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.