High powered ultrasound to treat pancreas cancer
| ISRCTN | ISRCTN56087634 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56087634 |
| IRAS number | 240471 |
| Secondary identifying numbers | Version 4 (11.01.19), IRAS 240471 |
- Submission date
- 15/05/2020
- Registration date
- 22/07/2021
- Last edited
- 10/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
High Intensity Focused Ultrasound (HIFU) uses a beam of high-energy ultrasound waves to kill cells by causing water inside the cells to heat up. This effect could be used to kill cells in a tumour. Ultrasound waves can be delivered to a specific point in the body, for example a tumour, under the surface of the skin. Doctors can control where to concentrate the ultrasound waves by using a device that can be used to visualise the inner body parts including the tumour during treatment. The device used to visualise the inner body parts is similar to the ultrasound devices used to look at unborn babies in pregnant women.
The aim of this study is to assess if High Intensity Focused ultrasound (HIFU) is safe and feasible in treatment of pancreatic cancers. The researchers also want to find out if this treatment has any beneficial effect in improving survival, reducing pain and improving quality of life in patients with pancreatic cancer. They would also like to assess any effects that the treatment has on symptoms experienced from the cancer. In addition, blood samples will be examined after the treatment to see if the immune system (which may play a role in preventing the growth of tumours) is affected by the treatment.
Who can participate?
Patients aged 18 years or older with pancreatic cancer
What does the study involve?
The study will test the ability of high powered ultrasound (HIFU) to treat pancreatic cancer. This will be assessed by performing MRI and CT scans before and after treatment. The treatment requires a general anaesthetic and a short hospital stay. It does not prevent patients from subsequently receiving chemotherapy. The researchers will also analyse blood samples to determine if the treatment causes an immune response against tumours.
What are the possible benefits and risks of participating?
The potential complications of the treatment itself are described below. In addition to the treatment
itself, the other medical interventions are: repeated blood tests, an MRI scan and an
additional CT scan. These carry some risks. Taking blood samples for blood tests can cause pain, bruising and rarely infection. MRI and CT scans carry some small risks. These include heating of metal objects about the person, which can cause burns. The contrast agent used as part of the scan can cause an allergic reaction (anaphylaxis) in sensitive individuals. Participants will have CT examinations of their chest, abdomen and pelvis, some of which will be extra to those that they would have if they did not take part. These procedures use ionising radiation to form images of the body. Ionising radiation can cause cell damage that may, after many years or decades, turn cancerous. The chance of this happening to participants is extremely small. The additional dose of radiation exposure by taking part in the study is equivalent to 8 years of background radiation. The aim of the treatment is to potentially destroy the cancer but HIFU has not yet been shown to reliably destroy pancreatic cancer and increase life expectancy. HIFU has been shown to reduce pain related to pancreatic cancer. The researchers are unable to give any guarantee as to whether the treatment will benefit you personally. The benefit of the trial is to society: the researchers hope to find out whether HIFU is safe and feasible in patients with pancreatic cancers. This study is also expected to give preliminary information regards effectiveness. This will help doctors in the future to make informed treatment decisions for patients. Further larger studies will be required to reliably assess whether HIFU treatment will benefit patients with pancreatic cancers.
Where is the study run from?
Churchill Hospital (UK)
When is the study starting and how long is it expected to run for?
February 2017 to June 2022
Who is funding the study?
Pancreatic Cancer Research Fund (UK)
Who is the main contact?
Katherine Gordon-Quayle (public), katherine.gordon-quayle@nds.ox.ac.uk
Keaton Jones (scientific), keaton.jones@ouh.nhs.uk
Contact information
Public
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
| Phone | +44 (0)1865 235944 |
|---|---|
| katherine.gordon-quayle@nds.ox.ac.uk |
Scientific
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
 ORCID ID |
0000-0002-4765-2167 |
|---|---|
| Phone | +44 (0)1865 235944 |
| keaton.jones@ouh.nhs.uk |
Study information
| Study design | Multicentre interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A multicentre phase II study to investigate the feasibility and safety of high intensity focused ultrasound in the treatment of pancreatic cancer |
| Study hypothesis | High Intensity Focused Ultrasound (HIFU) is a safe intervention for patients with locally advanced pancreatic cancer |
| Ethics approval(s) | Approved 17/06/2019, South Central - Oxford A Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 1048 045; oxforda.rec@hra.nhs.uk), REC ref: 19/SC/0095 |
| Condition | Locally advanced pancreatic cancer |
| Intervention | Patients with confirmed pancreatic cancer (with or without spread to other organs) who cannot be treated with surgery can participate in the trial. Participants will undergo an MRI scan to determine if the tumour can be treated using ultrasound. Blood tests will also be taken and stored securely. If this is possible, patients will be treated under general anaesthetic using a high powered ultrasound scan. This treatment passes through the skins and tissues and does not need any skin incisions. Patients usually stay in hospital for a few days (typically 3) to recover. Another MRI scan is performed 2 weeks after treatment to determine treatment response. Blood tests will again be taken and stored at this point. Finally, after 3 months a CT scan is performed. Blood samples from before and after treatment will be analysed to determine if there has been an immune reaction to the tumour. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | JC200 (Chongqing Haifu (HIFU) Technology Co., Ltd) |
| Primary outcome measure | Safety of HIFU therapy for pancreatic cancer measured using 30-day survival & adverse events and serious adverse events recorded using Clavien-Dindo grading |
| Secondary outcome measures | Feasibility of HIFU therapy : 1. Number of eligible patients agreeing to participate & proportion of enrolled participants completing treatment and follow up 2. Patient survival at 30 days, 3, 6 and 12 months 3. Treatment effect of HIFU on pancreatic cancer assessed using radiological evidence of tumour ablation on MRI at 30 days 4. Progression-free patient survival Imaging at 3, 6 and 12 months post-treatment or as indicated clinically 5. Immunological effects of HIFU treatment by regular measurement of leukocyte subsets at baseline, 14 days, 30 days and 3 months 6. Systemic response to HIFU treatment by regular measurement of CA 19-9 at baseline, 30 days, 3, 6 and 12 months 7. Patient experience of HIFU treatment using a questionnaire recording different aspects of patient experience during HIFU treatment admission at 2 weeks and 3 months following treatment 8. Patient-reported quality of life following HIFU treatment: ED-5D, EORTC QLQ-C30 and EORTC QLQ-PAN26 will be recorded at baseline, 72 hours, 30 days, 3, 6 and 12 months 9. Pain scores using Brief pain inventory at Baseline, 72 hours, 14 & 30 days, 3, 6 and 12 months |
| Overall study start date | 01/02/2017 |
| Overall study end date | 01/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Participant inclusion criteria | 1. Histologically or cytologically confirmed adenocarcinoma 2. Locally advanced inoperable pancreatic ductal adenocarcinoma and or operable pancreatic ductal cancers but patients not fit for surgery 3. A measurable primary tumour on ultrasound imaging, with a target area of less than 8 cm in diameter on CT/MRI 4. A clear 1 cm margin between the tumour and associated organs (duodenum, stomach, transverse colon) on contrast-enhanced MR imaging 5. Biliary obstruction to be relieved before inclusion in the study 6. Age greater than or equal to 18 years 7. Fit for general anaesthesia 8. Performance status: ECOG ≤2 9. An American Society of Anaesthesiologists (ASA) grade of ≤3 10. Life expectancy: At least 12 weeks 11. Able to attend for long-term follow-up 12. No concurrent malignancy 13. No serious medical or psychological condition 14. Ability to give fully informed consent |
| Participant exclusion criteria | 1. Patients with TNM Stage IV (metastatic disease) 2. Unclear cancer margins on ultrasound imaging 3. Invasion into the duodenal wall 4. Stricture of superior mesenteric artery directly by tumour encasement, or invasion of SMV below transverse mesocolon 5. Patient suitable for surgical resection 6. Refusal to give informed consent 7. Unable to give informed consent 8. Not fit for HIFU treatment: any significant disease, disorder, or finding which, in the opinion of the investigator, may significantly increase the risk to the patient because of participation in the study 9. Active or ongoing infection requiring IV antibiotics 10. Known pregnancy |
| Recruitment start date | 01/11/2019 |
| Recruitment end date | 01/11/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Headington
Oxford
OX3 7LE
United Kingdom
Sponsor information
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865 616554 |
|---|---|
| researchsupport@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- PancreaticCancer Res, PCRF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | 1. Planned publication in a high-impact peer-reviewed journal 2. The researchers plan to be open and transparent and share the results as widely as possible 2. No trial documents are currently published or available |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. The datasets pertaining to morbidity and mortality will be made available upon request. Patient-level data will not be released. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/05/2022: Internal review.
01/06/2021: Trial's existence confirmed by South Central - Oxford A Research Ethics Committee.
