Pilot Study of a Catheter-based Ultrasound Hyperthermia System

• ClinicalTrials.gov Identifier: NCT00911079
• Recruitment Status: Terminated
• First Posted: June 1, 2009
• Last Update Posted: July 7, 2021
• Sponsor: University of California, San Francisco
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): I-Chow Hsu, University of California, San Francisco

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• 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

More Information

• 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
• Last Update Posted: July 7, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Hyperthermia; Uterine Cervical Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries