Pancreatic AdenocarcinomaNCT04298242
Magnetic Resonance Guided High Intensity Focused Ultrasound in Advanced Pancreatic Adenocarcinoma Treatment
A study testing ExAblate 2100 in people with Pancreatic Adenocarcinoma, run by Stanford University at 1 site in United States.
Trial summary
The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity focused ultrasound device as an intervention for treatment of advanced stage pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- ExAblate 2100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2020to 15 Jun 2021
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years of age
- Patients willing to sign a written informed consent document
- Patients with unresectable, locally advanced or metastatic pancreatic adenocarcinoma
- Patients with upper abdominal pain rating at least 4 out of 10 in severity on BPI
- Tumor must be visualized on CT or MRI, obtained within 30 days of enrollment
- Tumor must be accessible to the ExAblate MRgFUS device
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- Life expectancy ≥ 3 months, as determined by oncologist and documented in chart
- ECOG performance status of 0, 1, or 2
- INR < 1.6, platelet count > 50,000 microL
- Serum urate, calcium, potassium, phosphate, creatinine < 1.5x upper limit of normal
- Patients can receive general anesthesia, as determined by anesthesiologist
Who cannot join
- Previous pancreatic surgery
- Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, claustrophobia, etc.
- Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR <30 mL/min/1.73 m2) or on dialysis
- Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
- Patients unable to receive general anesthesia
- Target is:
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- NOT visible by non-contrast MRI, OR
- NOT accessible to ExAblate device
- Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 6 hrs of total table time)
- Patients with acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study
- Patients with unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction within six months of protocol entry
- Congestive heart failure requiring medication (other than diuretic)
- Patients on anti-arrhythmic drugs
- Patients with severe hypertension (diastolic BP > 100 on medication)
- Patients with severe hematologic, neurologic, or other uncontrolled disease (e.g. platelets < 50,000/microL, INR > 1.5)
- Patients who are taking anti-thrombotic medication
- Severe cerebrovascular disease (multiple CVAs or CVA within 6 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Magnetic Resonance Guided High Intensity Focused Ultrasound for Treatment of Advanced Pancreatic Adenocarcinoma
The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity focused ultrasound device as an intervention for treatment of advanced stage pancreatic adenocarcinoma.
Read the detailed description
Primary Objective: The primary endpoints for this study will be 1) feasibility of ablation and 2) safety of ablation.
Secondary Objective: 1.)Pain reduction after ablation. 2.) Evidence of inflammation at ablation site based on histology, or in blood after ablation
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- ExAblate 2100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate 2100Device
Also called InSightec ExAblate 2100 MRgHIFU system
A non-invasive thermal ablation device fully integrated with an MR imaging system
| Study group | Role | What they receive |
|---|---|---|
| MRgFUS Treatment | Experimental | The pancreatic tumor will be ablated with magnetic resonance guided focused ultrasound (MRgFUS). Receives: Device: ExAblate 2100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure acceptable ablation percentage
Feasibility of ablation, as measured by the number of patients with acceptable ablation percentage. Acceptable ablation percentage is defined as ≥50% of the targeted volume appearing ablated on post-treatment imaging. Ablation will be deemed feasible if at least seven of the ten patients have an acceptable ablation percentage
Measured: Immediately after MRgFUS treatment
Total frequency and severity of adverse events
Safety of ablation, as measured by the total frequency and severity of adverse events. Adverse events will be categorized and grade for severity according to the Common Terminology Criteria for Adverse Events, Version 5.0. Ablation will be deemed safe if there are no treatment-related serious adverse events, and no more than five moderate or mild treatment-related adverse events, among the ten patients during follow up.
Measured: 24 months
Secondary outcomes (3)
Assess Pain Response assessed by the Brief Pain Inventory (BPI)
Reduction in pain level, as measured by:
- a decline in pain score after one week of at least 2 points, or a pain score < 4 out of 10, as assessed by the Brief Pain Inventory. Ablation will be deemed pain reducing if at least five of the ten patients have pain reduction.
Measured: Baseline, 1 week, and monthly for 24 months following treatment
Assess Pain Response assessed by morphine equivalent daily dose (MEDD)
Reduction in pain level will be measured by a decline after one week in morphine equivalent daily dose (MEDD) of 25%. Ablation will be deemed pain reducing if at least five of the ten patients have pain reduction.
Measured: Baseline, 1 week, and monthly for 24 months following treatment
Evidence of ablation-induced inflammation
Evidence of ablation-induced inflammation, defined as post-ablation increases in histologic and/or blood measures of inflammation markers, as measured by either:
- an increase in tumor infiltrating CD8+ T cells
- a decrease in immune suppressive cells (Tregs, macrophages) in the tumor
- an increase in immune activation signatures (including interferon gamma) in the tumor as measured by RNAseq
- a change in immune profile in the circulating immune cells (PBMCs) to reflect an activated immune response (e.g. activated T or B cells, reduction in immune suppressive cells or cytokines) Ablation will be deemed inflammation-inducing if at least five of the ten patients show at least a 50% increase in inflammation on at least 2 of the 4 markers
Measured: 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start22 Nov 2020
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pejman Ghanouni, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298242
- Sponsor's protocol ID
- IRB-52567
- Other IDs
- PANC0034, NCI-2020-13809
- Status last verified
- Nov 2023
- First submitted
- 4 Mar 2020
- Last updated
- 22 Nov 2023
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Magnetic Resonance Guided High Intensity Focused Ultrasound for Treatment of Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04298242
- Acronym / sponsor ID
- IRB-52567
- Conditions
- Pancreatic Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 22 Nov 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 6 Mar 2020 (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.
The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity focused ultrasound device as an intervention for treatment of advanced stage pancreatic adenocarcinoma.
Detailed description
Primary Objective: The primary endpoints for this study will be 1) feasibility of ablation and 2) safety of ablation.
Secondary Objective: 1.)Pain reduction after ablation. 2.) Evidence of inflammation at ablation site based on histology, or in blood after ablation
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRgFUS Treatment | Experimental | Device: ExAblate 2100The pancreatic tumor will be ablated with magnetic resonance guided focused ultrasound (MRgFUS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women ≥ 18 years of age
- Patients willing to sign a written informed consent document
- Patients with unresectable, locally advanced or metastatic pancreatic adenocarcinoma
- Patients with upper abdominal pain rating at least 4 out of 10 in severity on BPI
- Tumor must be visualized on CT or MRI, obtained within 30 days of enrollment
Key exclusion criteria (19 listed)
- Previous pancreatic surgery
- Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, claustrophobia, etc.
- Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR <30 mL/min/1.73 m2) or on dialysis
- Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
- Patients unable to receive general anesthesia
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 |
|---|---|---|
| ExAblate 2100Also: InSightec ExAblate 2100 MRgHIFU systemA non-invasive thermal ablation device fully integrated with an MR imaging system | Device | MRgFUS Treatment |
Primary outcome
Measure acceptable ablation percentage
Time frame: Immediately after MRgFUS treatment
Feasibility of ablation, as measured by the number of patients with acceptable ablation percentage. Acceptable ablation percentage is defined as ≥50% of the targeted volume appearing ablated on post-treatment imaging. Ablation will be deemed feasible if at least seven of the ten patients have an acceptable ablation percentage
Total frequency and severity of adverse events
Time frame: 24 months
Safety of ablation, as measured by the total frequency and severity of adverse events. Adverse events will be categorized and grade for severity according to the Common Terminology Criteria for Adverse Events, Version 5.0. Ablation will be deemed safe if there are no treatment-related serious adverse events, and no more than five moderate or mild treatment-related adverse events, among the ten patients during follow up.
3 secondary outcomes
Assess Pain Response assessed by the Brief Pain Inventory (BPI)
Time frame: Baseline, 1 week, and monthly for 24 months following treatment
Assess Pain Response assessed by morphine equivalent daily dose (MEDD)
Time frame: Baseline, 1 week, and monthly for 24 months following treatment
Evidence of ablation-induced inflammation
Time frame: 1week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- 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.
Pejman Ghanouni principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate 2100 in people with Pancreatic Adenocarcinoma, run by Stanford University at 1 site in United States.
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 11 inclusion and 19 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: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure acceptable ablation percentage (time frame: Immediately after MRgFUS treatment). 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 22 Nov 2023.