RecruitingNot ApplicableNCT05053555

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

60 participants

Start Date

Apr 24, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates high dose-rate brachytherapy (a type of internal radiation therapy where a radiation source is placed directly into or near the tumor) for liver tumors that cannot be surgically removed. It is being tested for both primary liver cancer and cancer that has spread to the liver. **You may be eligible if...** - You are 18 or older with up to five liver tumors that cannot be removed surgically - Your tumors are at least 3 cm in size and near blood vessels or other sensitive structures - The tumors are difficult to treat with other approaches (like targeted blood vessel therapy) **You may NOT be eligible if...** - You have an active untreated infection - You have other serious uncontrolled illnesses - You are not suitable for the procedure based on clinical assessment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEhigh dose rate brachytherapy

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

DEVICEhigh 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


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05053555


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