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

NCT02683200 | Completed Early Phase 1 DMC FDA Device

• 2 other identifiers: 15-000362NCI-2015-01665
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adult Hepatocellular Carcinoma; Metastatic Malignant Neoplasm in the Liver

Outcome Measures

Primary Outcomes (5)

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

  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

  Up to 2 years

• 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

  Up to 2 years

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

  Up to 2 years

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

  Up to 2 years

• 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

  Up to 2 tears

Secondary Outcomes (6)

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

  Up to 2 years

• DSS

  Up to 2 years

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

  Up to 2 years

• Infield tumor LC

  Up to 2 years

• OS

  Up to 2 years

Study Arms (1)

Treatment (MRI-guided Tri-60Co teletherapy SBRT)

EXPERIMENTAL

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

Radiation: Image-Guided Adaptive Radiation Therapy; Radiation: Stereotactic Body Radiation Therapy

Interventions

Image-Guided Adaptive Radiation Therapy RADIATION

Undergo MRI-guided Tri-60Co teletherapy SBRT

Also known as: IGART

Treatment (MRI-guided Tri-60Co teletherapy SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo MRI-guided Tri-60Co teletherapy SBRT

Also known as: SBRT

Treatment (MRI-guided Tri-60Co teletherapy SBRT)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ann Raldow, MD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: February 17, 2016
• Study Start: June 3, 2015
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: February 21, 2023

Record last verified: 2022-03

Locations

US (1)