High Dose Rate Brachyablation of Primary Liver Lesions

NCT02893982 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-05-18

No results posted yet for this study

Summary

The objectives of this study are to demonstrate feasibility of an optimized, image-guided pre-planned workflow to deliver at least 25 Gy to the periphery of the target lesion while maintaining established dose constraints to normal tissues, and to determine the maximum tolerated dose (MTD) while evaluating treatment delivery, safety, and efficacy utilizing a pre-planned and optimized image-guided workflow for percutaneous HDR brachytherapy of liver lesions.

Conditions

Interventions

RADIATION

brachytherapy

image-guided navigation of catheter placement for high dose rate (HDR) brachytherapy treatment of patients with primary liver lesions

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Michael Folkert, MD · UT Southwestern Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-09
Primary Completion
2020-03-16
Completion
2020-03-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02893982 on ClinicalTrials.gov