TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Liver Cancer

Treatments: Procedure: Y90-radioembolization procedure; Diagnostic Test: Angiogram; Device: TriSalus™ TriNav™Infusion System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05743842

2022-0769

NCI-2023-01620 (Other Identifier)

Details and patient eligibility

About

To learn if using the TriNav Infusion System (TriNav catheter) for the injection of the surrogate/test dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter.

Full description

Primary Objectives:

To determine the percentage of tumors that demonstrate quantitative mean dose concordance (within 20%) using voxel-level quantitative SPECT/CT between 99mTc-MAA treatment planning to post therapy Y90 microspheres with an FDA-cleared Pressure Enabled Drug DeliveryTM (PEDDTM) device.

Secondary Objectives:

To determine the correlation of T:N ratios of all tumors 3cm based on 99mTc-MAA SPECT/CT and Y90 SPECT/CT imaging.

To determine the fidelity and concordance of perfused normal liver uptake and distribution between 99mTc-MAA treatment planning to post therapy Y90 microspheres SPECT/CT.

To assess safety of TriNav catheter in this study population

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

TriSalus™ TriNav™Infusion System (catheter)

Experimental group

Description:

TriNav Infusion System (TriNav catheter) for the injection of the surrogate/test dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter

Treatment:

Device: TriSalus™ TriNav™Infusion System

Diagnostic Test: Angiogram

Procedure: Y90-radioembolization procedure