Radiation Device Treatment for Unremovable Liver Tumors

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with liver tumors that cannot be removed by surgery. It tests high dose-rate brachytherapy, a form of radiation placed inside the tumor.

Age

19 Years and older

Sex

All sexes can join.

Disease stage

Up to five liver tumors that cannot be removed by surgery and are at least 3 cm (1.2 in) across. They must be close to large blood vessels or sensitive structures (bowel, stomach, diaphragm, liver capsule, liver hilum, bile ducts), be hard to reach through the arteries (hypovascular tumors), or have a large shunt fraction to other vital organs.

Earlier treatment

A second group is made of past patients who fit the same criteria but did not receive HDRBT between 01/01/2000 and 1/01/2021.

Main reasons for not taking part

• Active infectious disease
• Uncontrolled other illness, such as active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
• Polymetastatic disease, except when treatment helps local problems from the target lesion, such as pain, vessel or bile duct blockage, or poor liver function
• Pregnancy
• Child-Pugh class C, total serum bilirubin above 2 mg/dl, platelet count below 50,000/ul, or INR above 1.5

The registry criteria, word for word

What the trial wants to find out

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).

The 2 groups in the trial

• Group A (Prospective cohort )Treatment being tested

  20 patients, will undergo initial diagnostic workup, staging and treatment per institutional standard of care. Intervention: High dose rate brachytherapy (HDRBT)

  Treatment: high dose rate brachytherapy

• Group B( Retrospective chart review )Treatment being tested

  40 patients who meet same eligibility criteria, but did not receive HDRBT between 1/1/2000 and 1/1/2021.

  Treatment: high dose rate brachytherapy