Tumor study: Y90 Microsphere Therapy
Official title PREDICTT Clinical Trial: Prospective Evaluation Of Pressure-Enabled Delivery And Alterations In CT-Based Tumor-To-Normal Liver Ratio And Tumor Dose Using The Trinav Infusion System
ClinicalTrials.gov ID: NCT07444645
What this study is testing
- What it's testing
- The study aims to compare CT‑based tumor‑to‑normal liver ratio measurements using TriNav versus endhole microcatheters.
- Who it's for
- Patients with liver tumors who can undergo CT imaging.
- What's involved
- Participants will receive the TriNav infusion system and have CT scans taken to assess tumor size and dose.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients over 18 years of age, of any race or sex, who have unresectable primary or metastatic tumors of the liver, and who are able to give informed...
- Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months
- At least one lesion ≥ 3.0 cm in shortest dimension
- Negative pregnancy test in premenopausal women with an acceptable contraception
- Plan to perform bilobar, lobar or sectoral treatment using partition dosimetry
You likely can't join if
- Contraindications to angiography and selective visceral catheterization
- Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single treatment session
- CT based TNR of 3 or higher based on planning hybrid angioCT
- Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate...
- Infiltrative tumors
See the full eligibility criteria
- Patients over 18 years of age, of any race or sex, who have unresectable primary or metastatic tumors of the liver, and who are able to give informed consent
- Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months
- At least one lesion ≥ 3.0 cm in shortest dimension
- Negative pregnancy test in premenopausal women with an acceptable contraception
- Plan to perform bilobar, lobar or sectoral treatment using partition dosimetry
- Evidence of partial or complete tumor vascularity based on pre-procedure liver protocol CT scan or MRI with contrast or intraprocedural hybrid angio CT as well as subjectively similar tumor vascularity between right and...
- Right or left hepatic artery diameter of 1.5 mm to 5 mm (the recommended vessel size range for the TriNav Infusion System) based on pre-procedure arterial phase CT or intraprocedural hybrid angio CT
- Contraindications to angiography and selective visceral catheterization
- Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single treatment session
- CT based TNR of 3 or higher based on planning hybrid angioCT
- 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)
- Infiltrative tumors
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, 18 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.