Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RA… (NCT03896646) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D)
United States42 participantsStarted 2019-10-10
Plain-language summary
This trial aims to improve hepatocellular carcinoma (HCC) tumor responses in patients undergoing Y90 radioembolization by using personalized dosimetry as part of treatment planning. Using standard calculations for Y90 doses may not be specific enough for individual patients given that there can be differences in how tumor cells and liver cells respond to radiation. Personalized dose plans may help improve treatment and outcomes in liver cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients over 18 years of age, of any race or sex, who have unresectable hepatocellular carcinoma of the liver, and who are able or have a fully able legal guardian to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of \</=2, with a life expectancy of \>/=3 months, and must be non-pregnant with an acceptable contraception in premenopausal women. Patients must be \>4 weeks since prior radiation or prior surgery and at least one month post chemotherapy.
. At least one lesion \>/= 3.0 cm in shortest dimension
. AST or ALT \<5 times ULN
. Bilirubin \</= 2.0 mg/dL (unless segmental infusion is used)
. Negative pregnancy test in premenopausal women
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Contraindications to angiography and selective visceral catheterization
. Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) to the lungs with a single injection, or greater than 50 Gy for multiple injections
. Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels)
. Significant extrahepatic disease representing an imminent life-threatening outcome
. Severe liver dysfunction or pulmonary insufficiency
. Active uncontrolled infection
. Significant underlying medical or psychiatric illness