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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To prospectively evaluate the clinical effectiveness of the use of high dose rate brachytherapy (HDRBT) for the treatment of both primary liver malignancies.
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)
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,261 Total Patients Enrolled
Joshua KubanPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have up to five tumors that cannot be surgically removed.My condition involves areas near important internal organs.I have cancer that has spread widely, but I need treatment for symptoms caused by a specific tumor.I am over 18 and have liver lesions.My liver disease is severe.I do not have any severe illnesses that could interfere with the study.My tumor is near major blood vessels.My tumor has poor blood supply, making it hard to access through blood vessels.I currently have an active infection.My condition involves a significant abnormal blood flow to vital organs.
Research Study Groups:
This trial has the following groups:- Group 1: Group A (Prospective cohort )
- Group 2: Group B( Retrospective chart review )
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment presently underway for this research project?
"According to the information presented on clinicaltrials.gov, this trial has been open for recruitment since April 24th 2022 and was amended most recently in October 20th 2022."
Answered by AI
How many participants have been included in this research project?
"Affirmative, according to clinicaltrials.gov this medical trial is attempting to enroll participants. It was first posted on April 24th 2022 and last updated on October 20th 2022. The study requires 60 individuals from 1 clinic location."
Answered by AI
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