Evaluating a new infusion system for liver cancer treatment planning
TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning
This study is testing a new infusion system to see if it helps deliver liver cancer treatment more accurately and safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05743842 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of the TriNav Infusion System in ensuring that the distribution of a test dose of 99mTc-MAA matches the actual treatment with Y90 microspheres during radioembolization for liver cancer. The primary objective is to determine the concordance of tumor dosimetry between these two methods using advanced imaging techniques. Secondary objectives include evaluating the correlation of tumor-to-normal liver uptake ratios and assessing the safety of the TriNav catheter in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with unresectable liver tumors who are eligible for Y90-radioembolization treatment.
Not a fit: Patients with contraindications to angiography or those with infiltrative tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of liver cancer treatment planning, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for treatment planning in liver cancer, but the specific use of the TriNav system is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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, and must be non-pregnant with an acceptable contraception in premenopausal women. * At least one lesion ≥ 3.0 cm in shortest dimension * Negative pregnancy test in premenopausal women Exclusion Criteria: * Contraindications to angiography and selective visceral catheterization * Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single injection. * 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 * Target vessel sizes outside of TriNav device prescribed diameter range of 1.5 - 3.5 mm
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Armeen Mahvash, MD — M.D. Anderson Cancer Center
- Study coordinator: Armeen Mahvash, MD
- Email: armeen.mahvash@mdanderson.org
- Phone: 713-563-7340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.