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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743842
• Other study ID #: 2022-0769
• Secondary ID: NCI-2023-01620
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Armeen Mahvash, MD
• Phone: 713-563-7340
• Email: armeen.mahvash[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Device:
• TriSalus™ TriNav™Infusion System
Given by Infusion

Diagnostic Test:
• Angiogram
X-ray photograph

Procedure:
• Y90-radioembolization procedure
procedure

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	TriSalus Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0		Through study completion; an average of 1 year.

External Links

•   MD Anderson Cancer Center