Recruiting

Brachytherapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05053555

Conditions

Liver Malignant Tumors

Cholangiocarcinoma Metastatic

Pancreatic Cancer

Melanoma

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

high dose rate brachytherapy

high dose rate brachytherapy

Study Details

Brief summary:

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.

Conditions

Liver Malignant Tumors

Cholangiocarcinoma Metastatic

Pancreatic Cancer

Melanoma

Study ID

NCT05053555

Start date

Apr 24, 2022

Status verified date

May, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

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.

Interventions

high dose rate brachytherapy

diagnostic workup, staging, and treatment per the institution standard of care

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Joshua Kuban, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-22.