Locally Advanced Cervical CancerNCT03977311
MR-Guided High-Intensity Focused Ultrasound in Conjunction With Radiation Therapy for the Treatment of Locally Advanced Cervical Cancer
A study testing Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) and Radiation therapy in people with Locally Advanced Cervical Cancer, run by Washington University School of Medicine.
Trial summary
In this study, safety and feasibility of MR-guided HIFU hyperthermia application will be assessed in patients diagnosed with locally advanced cervical cancer. This site has reasonable soft tissue pathways and depths for the ultrasound to access with limited osseous or air interference. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) and Radiation therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2021to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed histologically or cytologically confirmed locally advanced cervical cancer, FIGO Stage IB2 to IVA
- Measurable disease per RECIST 1.1.
- At least 18 years of age.
- ECOG performance status ≤ 3 (Karnofsky ≥ 60%)
- Planned treatment includes radiation therapy.
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Who cannot join
- Currently receiving any investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Pacemaker or other implantable device subject to radiofrequency interference in the ultrasound field.
- Claustrophobia or other contraindications for MRI.
About this study
Official title: A Pilot Study Evaluating the Safety and Feasibility of MR-Guided High-Intensity Focused Ultrasound in Conjunction With Radiation Therapy for the Treatment of Locally Advanced Cervical Cancer
In this study, safety and feasibility of MR-guided HIFU hyperthermia application will be assessed in patients diagnosed with locally advanced cervical cancer. This site has reasonable soft tissue pathways and depths for the ultrasound to access with limited osseous or air interference. Additionally, of cervical cancer patients who develop recurrence following standard treatment, approximately 1/3 will recur locally and an additional 1/3 recur both locally and distantly. Risk of local failure increases with higher FIGO staging. Therefore, patients with locally advanced cervical cancer stand to benefit from adjuvant hyperthermia to potentially increase local disease control outcomes. While MR-HIFU may conceivably increase risk for local complications such as fistula formation, these risks are felt to be acceptable given the potential morbidity of local disease failure, which often can only be addressed curatively by pelvic exenteration. In this study, testing will be performed within tumor volumes involving the cervix uteri. Heating will be to the therapeutic level of 41-42°C for 30-60 minutes, a commonly utilized therapeutic target. This session duration will be achieved in either a single session either before or after the radiotherapy fraction or in an optional two sessions of 15-30 minutes both before and after the radiotherapy fraction, for a total time of 30-60 minutes one day per week. This study will help to elucidate the feasibility of achieving and maintaining therapeutic hyperthermia within an entire tumor volume over the goal period of time of 30-60 minutes.
The investigators anticipate that successful completion of this study will lead to further clinical trials investigating the treatment efficacy in terms of added local control compared to traditional, standard-of-care radiotherapy.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU), Radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU)Device
-To be used in conjunction with radiation therapy in the treatment of locally advanced cervical carcinoma patients
Radiation therapyRadiation
-Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| MR-HIFU | Experimental | -The study team will determine the tumor volume to be treated per standard-of-care diagnostic MRI or CT imaging. An array of scans will be used to align the participant with the HIFU system, optimize heat delivery to the patients, and/or monitor aspects related to the participant such as motion. Vendor-provided software will be used with the participant in each position to create a customized treatment plan for heat delivery. The HIFU device will then be used to apply clinical levels (41-42°C) of heat to the tumor volume. Regions will be heated to the 41-42°C for up to 60 minutes in one session (either before or after radiation) on one day per five to ten standard radiation therapy fractions, with a maximum of 6 days of hyperthermia over the course of their standard, indicated radiation therapy treatment. Receives: Device: Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU); Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of MR-HIFU hyperthermia: number of participants who achieve a temperature at or above 41 degrees Celsius
-Measured by the number of participants who achieve a temperature at or above 41 degrees Celsius within the target region for 2/3 of the intended heating duration in at least 1 MR-HIFU hyperthermia session in at least 5/10 enrolled patients
Measured: Completion of all participants with their radiation treatment (estimated to be 38 months)
Number of device/treatment related adverse events recorded by frequency and severity
-Severity of adverse events per patient will be evaluated and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 standard published by the National Cancer Institute (NCI)
Measured: Through 12 months following completion of treatment (estimated to be 14 months)
Secondary outcomes (2)
Local control rate
-Fraction of patients who remain free of disease in the pelvis following treatment
Measured: Through 12 months after completion of treatment (estimated to be 14 months)
Comparison of Quality of life as measured by EORTC-QLQ-C30
-30 questions about health with 1 = not at all and 4 = very much
-. Estimate the average of the items that contribute to the scale; this is the raw score then use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score indicates a "worse" level of symptoms.
Measured: Pre-treatment, 3 months after completion of radiation, and 6 months after completion of radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start31 Dec 2021 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Why it stopped: PI decided not to go forward with study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Zoberi, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977311
- Sponsor's protocol ID
- 19-x066
- Status last verified
- Mar 2022
- First submitted
- 4 Jun 2019
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Safety and Feasibility of MR-Guided High-Intensity Focused Ultrasound in Conjunction With Radiation Therapy for the Treatment of Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT03977311
- Acronym / sponsor ID
- 19-x066
- Conditions
- Locally Advanced Cervical Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided not to go forward with study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, safety and feasibility of MR-guided HIFU hyperthermia application will be assessed in patients diagnosed with locally advanced cervical cancer. This site has reasonable soft tissue pathways and depths for the ultrasound to access with limited osseous or air interference. Additionally, of cervical cancer patients who develop recurrence following standard treatment, approximately 1/3 will recur locally and an additional 1/3 recur both locally and distantly. Risk of local failure increases with higher FIGO staging. Therefore, patients with locally advanced cervical cancer stand to benefit from adjuvant hyperthermia to potentially increase local disease control outcomes. While MR-HIFU may conceivably increase risk for local complications such as fistula formation, these risks are felt to be acceptable given the potential morbidity of local disease failure, which often can only be addressed curatively by pelvic exenteration. In this study, testing will be performed within tumor volumes involving the cervix uteri. Heating will be to the therapeutic level of 41-42°C for 30-60 minutes, a commonly utilized therapeutic target. This session duration will be achieved in either a single session either before or after the radiotherapy fraction or in an optional two sessions of 15-30 minutes both before and after the radiotherapy fraction, for a total time of 30-60 minutes one day per week. This study will help to elucidate the feasibility of achieving and maintaining therapeutic hyperthermia within an entire tumor volume over the goal period of time of 30-60 minutes.
The investigators anticipate that successful completion of this study will lead to further clinical trials investigating the treatment efficacy in terms of added local control compared to traditional, standard-of-care radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-HIFU | Experimental | Device: Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU), Radiation: Radiation therapy-The study team will determine the tumor volume to be treated per standard-of-care diagnostic MRI or CT imaging. An array of scans will be used to align the participant with the HIFU system, optimize heat delivery to the patients, and/or monitor aspects related to the participant such as motion. Vendor-provided software will be used with the participant in each position to create a customized treatment plan for heat delivery. The HIFU device will then be used to apply clinical levels (41-42°C) of heat to the tumor volume. Regions will be heated to the 41-42°C for up to 60 minutes in one session (either before or after radiation) on one day per five to ten standard radiation therapy fractions, with a maximum of 6 days of hyperthermia over the course of their standard, indicated radiation therapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed histologically or cytologically confirmed locally advanced cervical cancer, FIGO Stage IB2 to IVA
- Measurable disease per RECIST 1.1.
- At least 18 years of age.
- ECOG performance status ≤ 3 (Karnofsky ≥ 60%)
- Planned treatment includes radiation therapy.
Key exclusion criteria (5 listed)
- Currently receiving any investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Pacemaker or other implantable device subject to radiofrequency interference in the ultrasound field.
- Claustrophobia or other contraindications for MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU)-To be used in conjunction with radiation therapy in the treatment of locally advanced cervical carcinoma patients | Device | MR-HIFU |
| Radiation therapy-Standard of Care | Radiation | MR-HIFU |
Primary outcome
Feasibility of MR-HIFU hyperthermia: number of participants who achieve a temperature at or above 41 degrees Celsius
Time frame: Completion of all participants with their radiation treatment (estimated to be 38 months)
-Measured by the number of participants who achieve a temperature at or above 41 degrees Celsius within the target region for 2/3 of the intended heating duration in at least 1 MR-HIFU hyperthermia session in at least 5/10 enrolled patients
Number of device/treatment related adverse events recorded by frequency and severity
Time frame: Through 12 months following completion of treatment (estimated to be 14 months)
-Severity of adverse events per patient will be evaluated and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 standard published by the National Cancer Institute (NCI)
2 secondary outcomes
Local control rate
Time frame: Through 12 months after completion of treatment (estimated to be 14 months)
Comparison of Quality of life as measured by EORTC-QLQ-C30
Time frame: Pre-treatment, 3 months after completion of radiation, and 6 months after completion of radiation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Zoberi, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) and Radiation therapy in people with Locally Advanced Cervical Cancer, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of MR-HIFU hyperthermia: number of participants who achieve a temperature at or above 41 degrees Celsius (time frame: Completion of all participants with their radiation treatment (estimated to be 38 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.