High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies

May 19, 2026 updated by: M.D. Anderson Cancer Center

Over the past three decades, the treatment of both primary and secondary liver malignancies has been improved by the development and optimization of multiple minimally invasive thermal ablative therapies. These advances have resulted in a myriad of benefits for patients including decreased morbidity, mortality, as well as increased longevity and quality of life. However, these therapies can only be performed within certain parameters. Thermal ablative techniques such as radiofrequency ablation (RFA) and microwave ablation (MVA) are recommended for small lesions under 3 cm due to decreased efficacy when attempting to treat larger lesions. Additionally, large vessels in close proximity to a target lesion may result in heat dissipation, termed the "heat sink" effect, and result in incomplete ablation of the lesion. Furthermore, thermal ablative techniques cause off-target damage when utilized near sensitive structures such as the diaphragm, stomach, or bowel, and if performed near thermosensitive bile ducts, can result in cholestasis . Noting these limitations, percutaneous high-dose-rate brachytherapy was brought into clinical practice by Ricke et al. in Europe in 2002 . This therapy utilizes an iridium-192 (192Ir) isotope to administer a cytotoxic dose of radiation to a target lesion. It is not susceptible to heat sink effects and can also deliver radiation with the precision necessary to cause tumor death without destroying the integrity of neighboring structures. Additionally, it can be used to treat larger tumors (>3cm) as it is not associated the same size limitations as ablative techniques and can also be utilized to treat lesions that are not amenable to intra-arterial therapies (such as trans-arterial chemoembolization and yttrium-90 radioembolization).

Since its inception, HDRBT has been evaluated through multiple studies investigating its use to treat lesions throughout the body including both primary and secondary liver malignancies such as hepatocellular carcinoma (HCC), cholangiocarcinoma, metastasis to the liver from colorectal cancer, pancreatic cancer , melanoma , and breast cancer . Its use in treating lymph node metastases has also been investigated . These studies have demonstrated the feasibility, safety, and clinical effectiveness of this method, establishing it as a therapeutic option when use of thermal ablation therapies is restricted. Most studies however, have been retrospective and have been performed outside the United States.

Studying this therapy will add a crucial treatment option to our current armamentarium, filling a gap in currently available therapies and additionally allowing for further investigation of the use of HDRBT in a larger and more diverse population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objective

-To prospectively evaluate the clinical effectiveness of the use of high dose rate brachytherapy (HDRBT) for the treatment of both primary and secondary unresectable liver malignancies assessed by comparing local tumor control (LTC) rates at 6 months with a historical cohort.

Secondary Objectives

  • To compare local tumor control rates at 3-month intervals between cohorts for the duration of the study (3 months, 9 months, 12 months, etc.).
  • To compare overall survival (OS) and progression-free survival (PFS) between cohorts.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Joshua Kuban, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • GROUP A: Patients with liver lesions must be over the age of 18

  • GROUP A: Any patient with up to five unresectable tumors that are:

    • At least 3 cm (largest diameter in the axial plane)
    • In close proximity to large blood vessels
    • In close proximity to sensitive structures (bowel, stomach, diaphragm, liver capsule, liver hilum, bile ducts)
    • Associated with difficult endovascular access to one or more feeding arterial branches (hypovascular tumors)
    • Associated with a large shunt fraction to other vital organs
  • GROUP B: Historical patients who meet the above criteria for group A but did not receive HDRBT between 01/01/2000 and 1/01/2021

Exclusion criteria:

  • Active infectious disease
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with polymetastatic disease with the exception of those patients who may benefit from therapy addressing local complications directly related to the target lesion diminishing quality of life such as pain, vascular/biliary occlusion, and liver disfunction
  • Pregnancy (sexually active patients must be on birth control while participating in this study)
  • Child-Pugh class C
  • Total serum bilirubin > 2 mg/dl
  • Platelet count < 50,000/ul
  • International normalized ratio (INR) > 1.5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Prospective cohort )
20 patients, will undergo initial diagnostic workup, staging and treatment per institutional standard of care. Intervention: High dose rate brachytherapy (HDRBT)
Device: high dose rate brachytherapy
diagnostic workup, staging, and treatment per the institution standard of care
Device: high dose rate brachytherapy
reviewing historical patients who meet the above criteria for group A but did not receive HDRBT between 01/01/2000 and 1/01/2021
Experimental: Group B( Retrospective chart review )
40 patients who meet same eligibility criteria, but did not receive HDRBT between 1/1/2000 and 1/1/2021.
Device: high dose rate brachytherapy
diagnostic workup, staging, and treatment per the institution standard of care
Device: high dose rate brachytherapy
reviewing historical patients who meet the above criteria for group A but did not receive HDRBT between 01/01/2000 and 1/01/2021

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To prospectively evaluate the clinical effectiveness of the use of high dose rate brachytherapy (HDRBT) for the treatment of both primary liver malignancies.
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Joshua Kuban, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2022

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1255
  • NCI-2021-09408 (Other Identifier: Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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