Back to resultsTriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning
Primary Purpose
Liver Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TriSalus™ TriNav™Infusion System
Angiogram
Y90-radioembolization procedure
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Cancer
Eligibility 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
Sites / Locations
- MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TriSalus™ TriNav™Infusion System (catheter)
Arm 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
Outcomes
Primary Outcome Measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Secondary Outcome Measures
Full Information
NCT ID
NCT05743842
First Posted
February 15, 2023
Last Updated
September 22, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
TriSalus Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05743842
Brief Title
TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning
Official Title
TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
TriSalus Life Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TriSalus™ TriNav™Infusion System (catheter)
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
TriSalus™ TriNav™Infusion System
Intervention Description
Given by Infusion
Intervention Type
Diagnostic Test
Intervention Name(s)
Angiogram
Intervention Description
X-ray photograph
Intervention Type
Procedure
Intervention Name(s)
Y90-radioembolization procedure
Intervention Description
procedure
Primary Outcome Measure Information:
Title
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time Frame
Through study completion; an average of 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armeen Mahvash, MD
Phone
713-563-7340
Email
armeen.mahvash@mdanderson.org
First Name & Middle Initial & Last Name or Official Title & Degree
Maria C Dimayuga
Phone
(832) 792-1692
Email
mcbrione@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armeen Mahvash, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armeen Mahvash, MD
Phone
713-563-7340
Email
armeen.mahvash@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Armeen Mahvash, MD
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center
Learn more about this trial
TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning
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