ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-14

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05743842

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Armeen Mahvash, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Armeen Mahvash, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-14

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-03-14

Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

Liver Cancer