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Pilot Study of a Catheter-based Ultrasound Hyperthermia System

Primary Purpose

Cervical Cancer, Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperthermia
HDR brachytherapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Cervical Cancer focused on measuring Stage III, IV cervical cancer, Rising prostate specific antigen (PSA) after local therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are to be given HDR brachytherapy for treatment of solid tumor of the following:

    • Cervical cancer Stage III or IV OR
    • Prostate cancer (with rising prostate specific antigen after prior local therapy)
  • Age >=18 years
  • Eligible for brachytherapy as determined per clinical standard of care.
  • Ability to give written informed consent and willingness to comply with the requirements of the protocol

Exclusion Criteria:

  • Patients who are not candidates for HDR brachytherapy
  • Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperthermia with HDR brachytherapy

Arm Description

Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session

Outcomes

Primary Outcome Measures

Frequency of treatment-related toxicities by treatment type
All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 and presented separately for the first and second hyperthermia treatments.
Frequency of treatment-related toxicities by accrual plan
All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 presented for the 2 subsets of patients corresponding to the plan for accrual: the first 3 patients with gynecologic cancer, then the final 9 patients with gynecologic cancer; and the first 3 patients with prostate cancer, then the final 9 patients with prostate cancer
Proportion of patients treated according to the specified temperature and timing criteria.
The feasibility of administering hyperthermia to patients receiving standard brachytherapy will be summarized by the proportion of patients completing the treatment as planned. The proportion and 95% confidence interval will be calculated for each of the two hyperthermia sessions

Secondary Outcome Measures

Average maximum prostate temperature (Tmax)
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Minimum temperature (Tmin)
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Median temperature (T50)
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Number of times temperature exceeded by 90% of the measured temperature points (T90)
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Cumulative Equivalent Minutes at 43 degree celsius (ºC) for 90% of the measured points (CEM43T90)
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment

Full Information

First Posted
May 29, 2009
Last Updated
June 30, 2021
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00911079
Brief Title
Pilot Study of a Catheter-based Ultrasound Hyperthermia System
Official Title
Pilot Study of a Catheter-based Ultrasound Hyperthermia System
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Low Accrual
Study Start Date
December 18, 2009 (Actual)
Primary Completion Date
July 23, 2020 (Actual)
Study Completion Date
July 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
OUTLINE: Patients undergo standard high-dose rate (HDR) brachytherapy. Approximately 2 hours after brachytherapy, patients undergo catheter-based ultrasound hyperthermia therapy over 60 minutes. Treatment with HDR brachytherapy and hyperthermia therapy repeats within 1-3 weeks. Patients may then undergo 2 additional standard HDR brachytherapy sessions. After completion of study therapy, patients are followed at 1 and 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Prostate Cancer
Keywords
Stage III, IV cervical cancer, Rising prostate specific antigen (PSA) after local therapy

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperthermia with HDR brachytherapy
Arm Type
Experimental
Arm Description
Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session
Intervention Type
Procedure
Intervention Name(s)
Hyperthermia
Intervention Description
Single course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy)
Intervention Type
Radiation
Intervention Name(s)
HDR brachytherapy
Intervention Description
Completion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants
Primary Outcome Measure Information:
Title
Frequency of treatment-related toxicities by treatment type
Description
All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 and presented separately for the first and second hyperthermia treatments.
Time Frame
Up to 3 months
Title
Frequency of treatment-related toxicities by accrual plan
Description
All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 presented for the 2 subsets of patients corresponding to the plan for accrual: the first 3 patients with gynecologic cancer, then the final 9 patients with gynecologic cancer; and the first 3 patients with prostate cancer, then the final 9 patients with prostate cancer
Time Frame
Up to 3 months
Title
Proportion of patients treated according to the specified temperature and timing criteria.
Description
The feasibility of administering hyperthermia to patients receiving standard brachytherapy will be summarized by the proportion of patients completing the treatment as planned. The proportion and 95% confidence interval will be calculated for each of the two hyperthermia sessions
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Average maximum prostate temperature (Tmax)
Description
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Time Frame
Up to 4 weeks
Title
Minimum temperature (Tmin)
Description
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Time Frame
Up to 4 weeks
Title
Median temperature (T50)
Description
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Time Frame
Up to 4 weeks
Title
Number of times temperature exceeded by 90% of the measured temperature points (T90)
Description
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Time Frame
Up to 4 weeks
Title
Cumulative Equivalent Minutes at 43 degree celsius (ºC) for 90% of the measured points (CEM43T90)
Description
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are to be given HDR brachytherapy for treatment of solid tumor of the following: Cervical cancer Stage III or IV OR Prostate cancer (with rising prostate specific antigen after prior local therapy) Age >=18 years Eligible for brachytherapy as determined per clinical standard of care. Ability to give written informed consent and willingness to comply with the requirements of the protocol Exclusion Criteria: Patients who are not candidates for HDR brachytherapy Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Chow J. Hsu, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-1708
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Study of a Catheter-based Ultrasound Hyperthermia System

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