PainPhase 1/2HIFU PancreasNCT00637364
High Intensity Focused Ultrasound Tumor Treatment for Pancreatic Cancer Pain
A Phase 1/2 study testing High intensity focused ultrasound, HIFU in people with Pain and Pancreatic Adenocarcinoma, run by CMED HIFU Development Corporation at 1 site in United States.
Trial summary
This is an open-label, non-randomized, single-center, therapeutic trial in patients with AJCC Stage III or IV pancreatic cancer with tumor related abdominal and/or back pain to evaluate the safety of high intensity focused ultrasound therapy using the FEP-BY02 HIFU system for palliation of pancreatic cancer-related… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Pancreatic Adenocarcinoma, Ductal Adenocarcinoma
- What is being tested?
- High intensity focused ultrasound, HIFU
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jul 2010
- Phase
- Phase 1/2
- 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
- Age older than 18 years
- Histology proven pancreatic ductal adenocarcinoma in the body or tail of the pancreas with a 1 cm margin of tissue to all named vessels and adjacent organs
- AJCC stage III or IV pancreatic cancer based on imaging criteria (endoscopic ultrasound, CT scan, and/or MRI)
- Presence of mid-abdominal pain or back pain (>=4 at its worst on Brief Pain Inventory) in the week prior to baseline evaluation or requiring any dose of opioid narcotic for pain relief
- Pancreatic tumor that can be evaluated by RECIST criteria
- Pancreatic tumor that can be imaged with transabdominal ultrasonography
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- Pancreatic tumors with an adequate window for the HIFU beam without intervening air or colon
- No contraindications for CT/PET imaging
- Karnofsky's performance status of 50% or greater
- Life expectancy greater than 3 months
- Normal coagulation profile (INR <1.6; platelet count >50,000)
- American Society of Anesthesiologists (ASA) class =/<2, not including patient's diagnosis of pancreatic carcinoma
- Normal serum uric acid, calcium, potassium, phosphate and creatinine values
- Willingness and ability to complete follow-up interviews for 24 months following the last HIFU treatment
Who cannot join
- Previous pancreatic surgery or resection
- Have had previous surgery to remove jaundice causing obstruction
- Active malignancy (not including metastases) or history of other primary source of cancer other than pancreas except for basal cell carcinoma or carcinoma-in-situ of the cervix
- Any other disease, condition or surgery which might confound HIFU therapy, including the requirement for the patient to remain still in the supine position for 90 minutes
- Inability to image the pancreatic tumor with ultrasound
- The presence of bone (e.g., ribs) in the path of the HIFU beam
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- The presence of colon in the path of the HIFU beam
- Use of aspirin containing or aspirin-analog products, including herbal supplements that may decrease coagulation, within two weeks of first HIFU treatment
- Currently a prisoner
- Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia)
- Pregnancy at time of enrollment, since this would contraindicate HIFU therapy
- Participation in any other investigational drug, biologic or medical device study within the 30 days prior to the study enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Non-Randomized, Single-Center, Therapeutic Trial Examining the Feasibility, Safety, and Efficacy of FEP-BY02, a High Intensity Focused Ultrasound Tumor Treatment Device, in Patients With Pancreatic Cancer Pain
This is an open-label, non-randomized, single-center, therapeutic trial in patients with AJCC Stage III or IV pancreatic cancer with tumor related abdominal and/or back pain to evaluate the safety of high intensity focused ultrasound therapy using the FEP-BY02 HIFU system for palliation of pancreatic cancer-related pain. Patients meeting all eligibility criteria without any exclusion criteria will be offered an opportunity to participate in the study. After obtaining informed consent a baseline history, physical examination, laboratory studies, and any additional imaging studies needed will be performed.
The major theoretic risk to the patient with this procedure is the development of acute pancreatitis. If acute pancreatitis were to develop, it should become clinically evident by day 3 following HIFU ablation. Therefore, the initial phase of this pilot study is designed to allow a sufficient interval between HIFU treatments to identify whether this theoretic risk will manifest clinically. Previous clinical experience in China suggests that HIFU of pancreatic tumors is safe without risk of developing severe acute pancreatitis.
Read more
Patients treated with HIFU will have approximately 15-20% of the tumor volume treated per session. The first 5 patients (feasibility study) will receive their first HIFU treatment followed by a 3-5 day interval for observation.
Following the feasibility study the results will be reviewed with the FDA. If no serious adverse events are encountered, and the FDA agrees with continuing the study, then the next 5 patients will be treated with an interval of 2-3 days between each treatment. If no serious adverse events are encountered in this group, then the next group of 5 patients will be treated at intervals of 1-2 days between each treatment.
- Conditions
- Pain, Pancreatic Adenocarcinoma, Ductal Adenocarcinoma
- Being tested
- High intensity focused ultrasound, HIFU
- Keywords
- pain, pancreas, pancreatic cancer, pancreatic adenocarcinoma, ductal adenocarcinoma
- Medical subject headings
- Pain, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity focused ultrasound, HIFUProcedure or surgery
The FEP-BY02 HIFU system uses extracorporeal generated high intensity ultrasound, focused on a tumor region of interest, to ablate tissue. A stand-alone B-mode ultrasound is used to locate and define the tumor region of interest. Once defined, the acoustic energy is delivered using a large aperture; fixed focus; sparse transducer array. The concentration of acoustic energy may result in thermal and/or mechanical bioeffects including tissue necrosis, apoptosis, and/or disruption (temporary or permanent) of normal cellular function within the targeted volume (such as nerve conduction).
The FEP-BY02 High Intensity Focused Ultrasound (HIFU) system is intended to ablate ductal adenocarcinoma of the pancreas with ultrasound-guided targeted delivery of focused ultrasound energy to effect thermal and/or mechanical bioeffects leading to ablation (destruction) of the targeted tumor tissue.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the FEP-BY02 HIFU system determined by the frequency and severity of adverse events (AEs) categorized and graded for severity according to the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE)
Measured: pre treatment, post treatment, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2010 (estimated)
Why it stopped: Sponsor is not proceeding with USA human trial at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMED HIFU Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joo Ha Hwang, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637364
- Sponsor's protocol ID
- FEP-BY02-01
- Other IDs
- WIRB 20071832
- Acronym
- HIFU Pancreas
- Status last verified
- Jan 2009
- First submitted
- 12 Mar 2008
- Last updated
- 13 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Non-Randomized, Single-Center, Therapeutic Trial Examining the Feasibility, Safety, and Efficacy of FEP-BY02, a High Intensity Focused Ultrasound Tumor Treatment Device, in Patients With Pancreatic Cancer Pain
- ClinicalTrials.gov ID
- NCT00637364
- Acronym / sponsor ID
- HIFU Pancreas / FEP-BY02-01
- Conditions
- Pain, Pancreatic Adenocarcinoma, Ductal Adenocarcinoma
- Keywords
- pain, pancreas, pancreatic cancer, pancreatic adenocarcinoma, ductal adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor is not proceeding with USA human trial at this time
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- CMED HIFU Development CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jul 2010 (estimated)
- First posted
- 18 Mar 2008 (estimated)
- 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.
This is an open-label, non-randomized, single-center, therapeutic trial in patients with AJCC Stage III or IV pancreatic cancer with tumor related abdominal and/or back pain to evaluate the safety of high intensity focused ultrasound therapy using the FEP-BY02 HIFU system for palliation of pancreatic cancer-related pain. Patients meeting all eligibility criteria without any exclusion criteria will be offered an opportunity to participate in the study. After obtaining informed consent a baseline history, physical examination, laboratory studies, and any additional imaging studies needed will be performed.
The major theoretic risk to the patient with this procedure is the development of acute pancreatitis. If acute pancreatitis were to develop, it should become clinically evident by day 3 following HIFU ablation. Therefore, the initial phase of this pilot study is designed to allow a sufficient interval between HIFU treatments to identify whether this theoretic risk will manifest clinically. Previous clinical experience in China suggests that HIFU of pancreatic tumors is safe without risk of developing severe acute pancreatitis.
Patients treated with HIFU will have approximately 15-20% of the tumor volume treated per session. The first 5 patients (feasibility study) will receive their first HIFU treatment followed by a 3-5 day interval for observation.
Following the feasibility study the results will be reviewed with the FDA. If no serious adverse events are encountered, and the FDA agrees with continuing the study, then the next 5 patients will be treated with an interval of 2-3 days between each treatment. If no serious adverse events are encountered in this group, then the next group of 5 patients will be treated at intervals of 1-2 days between each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age older than 18 years
- Histology proven pancreatic ductal adenocarcinoma in the body or tail of the pancreas with a 1 cm margin of tissue to all named vessels and adjacent organs
- AJCC stage III or IV pancreatic cancer based on imaging criteria (endoscopic ultrasound, CT scan, and/or MRI)
- Presence of mid-abdominal pain or back pain (>=4 at its worst on Brief Pain Inventory) in the week prior to baseline evaluation or requiring any dose of opioid narcotic for pain relief
- Pancreatic tumor that can be evaluated by RECIST criteria
Key exclusion criteria (12 listed)
- Previous pancreatic surgery or resection
- Have had previous surgery to remove jaundice causing obstruction
- Active malignancy (not including metastases) or history of other primary source of cancer other than pancreas except for basal cell carcinoma or carcinoma-in-situ of the cervix
- Any other disease, condition or surgery which might confound HIFU therapy, including the requirement for the patient to remain still in the supine position for 90 minutes
- Inability to image the pancreatic tumor with ultrasound
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 |
|---|---|---|
| High intensity focused ultrasound, HIFUThe FEP-BY02 HIFU system uses extracorporeal generated high intensity ultrasound, focused on a tumor region of interest, to ablate tissue. A stand-alone B-mode ultrasound is used to locate and define the tumor region of interest. Once defined, the acoustic energy is delivered using a large aperture; fixed focus; sparse transducer array. The concentration of acoustic energy may result in thermal and/or mechanical bioeffects including tissue necrosis, apoptosis, and/or disruption (temporary or permanent) of normal cellular function within the targeted volume (such as nerve conduction). The FEP-BY02 High Intensity Focused Ultrasound (HIFU) system is intended to ablate ductal adenocarcinoma of the pancreas with ultrasound-guided targeted delivery of focused ultrasound energy to effect thermal and/or mechanical bioeffects leading to ablation (destruction) of the targeted tumor tissue. | Procedure or surgery | – |
Primary outcome
Safety of the FEP-BY02 HIFU system determined by the frequency and severity of adverse events (AEs) categorized and graded for severity according to the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE)
Time frame: pre treatment, post treatment, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2009.
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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.
Joo Ha Hwang, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing High intensity focused ultrasound, HIFU in people with Pain and Pancreatic Adenocarcinoma, run by CMED HIFU Development Corporation 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 14 inclusion and 12 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: paused, as of the sponsor's last update on 13 Jan 2009. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Safety of the FEP-BY02 HIFU system determined by the frequency and severity of adverse events (AEs) categorized and graded for severity according to the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE) (time frame: pre treatment, post treatment, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, 24 months). 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 13 Jan 2009.