Liver Malignant Tumors study: High dose rate brachytherapy
Official title High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies
ClinicalTrials.gov ID: NCT05053555
What this study is testing
- What it's testing
- The study will evaluate how safe and effective this radiation technique is for liver tumors that are too big or in difficult locations for heat‑based ablation. It will also compare the results to previous reports from outside the U.S.
- Who it's for
- Adults with liver cancer or liver metastases that cannot be removed surgically and are not suitable for standard heat‑based ablation.
- What's involved
- Participants will receive a small radioactive seed (iridium‑192) placed directly into the tumor. They will have imaging scans, blood tests, and follow‑up visits to monitor the treatment and any side effects.
- Time commitment
- The treatment course lasts a few days, with follow‑up visits over several months to track tumor response and safety.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- GROUP A: Patients with liver lesions must be over the age of 18
- 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)
You likely can't join if
- Active infectious disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart...
- Patients with polymetastatic disease with the exception of those patients who may benefit from therapy addressing local complications directly...
- Pregnancy (sexually active patients must be on birth control while participating in this study)
- Child-Pugh class C
- Total serum bilirubin \> 2 mg/dl
See the full eligibility criteria
- GROUP A: Patients with liver lesions must be over the age of 18
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.