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Pilot Study of a Catheter-based Ultrasound Hyperthermia System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00911079
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
I-Chow Hsu, University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Prostate Cancer Procedure: Hyperthermia Radiation: HDR brachytherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Pilot Study of a Catheter-based Ultrasound Hyperthermia System
Actual Study Start Date : December 18, 2009
Actual Primary Completion Date : July 23, 2020
Actual Study Completion Date : July 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Ultrasound

Arm Intervention/treatment
Experimental: Hyperthermia with HDR brachytherapy
Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session
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




Primary Outcome Measures :
  1. Frequency of treatment-related toxicities by treatment type [ Time Frame: Up to 3 months ]
    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.

  2. Frequency of treatment-related toxicities by accrual plan [ Time Frame: Up to 3 months ]
    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

  3. Proportion of patients treated according to the specified temperature and timing criteria. [ Time Frame: Up to 4 weeks ]
    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 :
  1. Average maximum prostate temperature (Tmax) [ Time Frame: Up to 4 weeks ]
    Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment

  2. Minimum temperature (Tmin) [ Time Frame: Up to 4 weeks ]
    Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment

  3. Median temperature (T50) [ Time Frame: Up to 4 weeks ]
    Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment

  4. Number of times temperature exceeded by 90% of the measured temperature points (T90) [ Time Frame: Up to 4 weeks ]
    Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment

  5. Cumulative Equivalent Minutes at 43 degree celsius (ºC) for 90% of the measured points (CEM43T90) [ Time Frame: Up to 4 weeks ]
    Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911079


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-1708
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
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Principal Investigator: I-Chow J. Hsu, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by I-Chow Hsu, University of California, San Francisco:
Informed Consent Form  [PDF] July 25, 2019

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Responsible Party: I-Chow Hsu, Professor, Radiation Oncology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00911079    
Other Study ID Numbers: CDR0000643085
08992 ( Other Identifier: University of California, San Francisco )
5R01CA122276 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by I-Chow Hsu, University of California, San Francisco:
Stage III, IV cervical cancer
Rising prostate specific antigen (PSA) after local therapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Fever
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Body Temperature Changes