Clinical trial · Interventional
Pilot Study of a Catheter-based Ultrasound Hyperthermia System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low Accrual
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDR brachytherapy | Radiation | — | UNRESOLVED |
| Hyperthermia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyperthermia with HDR brachytherapy
- description
- Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session
- interventionNames
- Procedure: Hyperthermia
- Radiation: HDR brachytherapy
Primary outcomes (3)
- measure
- Frequency of treatment-related toxicities by treatment type
- timeFrame
- Up to 3 months
- 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.
- measure
- Frequency of treatment-related toxicities by accrual plan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available