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Pilot Study of a Catheter-based Ultrasound Hyperthermia System

NCT00911079 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-07-07

No results posted yet for this study

Summary

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells.

PURPOSE: This clinical trial is studying ultrasound hyperthermia therapy to see how well it works after implant radiation therapy in treating patients with Stage III/IV cancer of the cervix or prostate cancer with a rising prostate specific antigen (PSA) after prior local therapy.

Conditions

Interventions

PROCEDURE

Hyperthermia

Single course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy)

RADIATION

HDR brachytherapy

Completion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants

Sponsors & Collaborators

Principal Investigators

  • I-Chow J. Hsu, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-18
Primary Completion
2020-07-23
Completion
2020-07-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00911079 on ClinicalTrials.gov