NCT07444645 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
| NCT ID | NCT07444645 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-08-01 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This single-arm prospective study will compare CT-based tumor-to-normal ratio (TNR) measurements obtained using TriNav versus endhole microcatheters.
Eligibility Criteria
Inclusion Criteria: 1. 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 2. Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months 3. At least one lesion ≥ 3.0 cm in shortest dimension 4. Negative pregnancy test in premenopausal women with an acceptable contraception 5. Plan to perform bilobar, lobar or sectoral treatment using partition dosimetry 6. 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 left lobes if bilobar treatment is planned 7. 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 Exclusion Criteria: 1. Contraindications to angiography and selective visceral catheterization 2. Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single treatment session 3. CT based TNR of 3 or higher based on planning hybrid angioCT 4. 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) 5. Infiltrative tumors
Contact & Investigator
Peiman Habibollahi, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT07444645 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07444645 currently recruiting?
Yes, NCT07444645 is actively recruiting participants. Contact the research team at phabibollahi@mdanderson.org for enrollment information.
Where is the NCT07444645 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07444645 clinical trial?
NCT07444645 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Peiman Habibollahi, MD at M.D. Anderson Cancer Center. The trial plans to enroll 20 participants.