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Brachytherapy

High Dose-Rate Brachytherapy for Liver Cancer

N/A

Recruiting

Led By Joshua Kuban

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- In close proximity to sensitive structures (bowel, stomach, diaphragm, liver capsule, liver hilum, bile ducts)

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

Must not have

Child-Pugh class C

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study a new way to treat cancer using high-dose-rate brachytherapy (HDRBT), which is a type of radiation therapy. This therapy uses an iridium-192 (192Ir) isotope to administer a cytotoxic dose of radiation to a target lesion, and is not susceptible to heat sink effects.

Who is the study for?

This trial is for adults over 18 with liver lesions larger than 3 cm, near large blood vessels or sensitive areas like the bowel. It's also for those with up to five unresectable tumors that are hard to treat due to poor blood vessel access or have a high risk of affecting other organs. People can't join if they're pregnant, have serious illnesses like heart failure, active infections, severe liver disease (Child-Pugh class C), very high bilirubin levels in their blood, low platelets count, or an INR > 1.5.

What is being tested?

The study tests high-dose rate brachytherapy (HDRBT) using an iridium-192 isotope on primary and secondary liver malignancies which are not suitable for thermal ablation therapies. HDRBT aims to precisely target tumor cells without damaging nearby structures and can treat larger tumors effectively.

What are the potential side effects?

Potential side effects may include localized pain at the treatment site, fatigue from radiation exposure, possible damage to surrounding tissues leading to complications such as bleeding or infection; however precise targeting aims to minimize these risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition involves areas near important internal organs.

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I am over 18 and have liver lesions.

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My tumor is near major blood vessels.

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My tumor has poor blood supply, making it hard to access through blood vessels.

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My condition involves a significant abnormal blood flow to vital organs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver disease is severe.

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I do not have any severe illnesses that could interfere with the study.

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I currently have an active infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B( Retrospective chart review )Experimental Treatment1 Intervention

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

Group II: Group A (Prospective cohort )Experimental Treatment1 Intervention

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

0 / 8Eligibility criteria met