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Trial Title:
TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning
NCT ID:
NCT05743842
Condition:
Liver Cancer
Conditions: Official terms:
Liver Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
TriSalus™ TriNav™Infusion System
Description:
Given by Infusion
Arm group label:
TriSalus™ TriNav™Infusion System (catheter)
Intervention type:
Diagnostic Test
Intervention name:
Angiogram
Description:
X-ray photograph
Arm group label:
TriSalus™ TriNav™Infusion System (catheter)
Intervention type:
Procedure
Intervention name:
Y90-radioembolization procedure
Description:
procedure
Arm group label:
TriSalus™ TriNav™Infusion System (catheter)
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Armeen Mahvash, MD
Phone:
713-563-7340
Email:
armeen.mahvash@mdanderson.org
Contact backup:
Last name:
Armeen Mahvash, MD
Start date:
March 14, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
TriSalus Life Sciences
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05743842
http://www.mdanderson.org
