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

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.

Conditions

Liver Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Liver Cancer
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

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

Study Record Dates

2027-12-31