Using MRI to predict the success of anticancer treatment before surgery to the esophagus (gullet) and the gastroesophageal junction (gullet-stomach junction)
| ISRCTN | ISRCTN35827514 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35827514 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/05/2018
- Registration date
- 22/05/2018
- Last edited
- 01/03/2021
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Cancer in the esophagus (gullet) and the gastroesophageal junction (gullet-stomach junction) are serious diseases. Despite diagnostic and treatment progress in recent years, only around 1 in 5 (20%) of the patients who gets these diseases can be cured. The best treatment results are achieved with a combination of anticancer treatments (radiation and drug treatment) followed by surgery. This combination therapy is effective on a group level, but for the individual patient it is very hard to know if the radiation therapy and chemotherapy (medicines) will be effective. If this could be known for each patient, a better tailor-made treatment plan could achieved. We want to improve the ability to see who responds well to this treatment before surgery and promising results from MRI in other types of tumors gives us hope that we can do this for esophageal and gastroesophageal junctional cancer as well.
Who can participate?
Adults over the age of 17.
What does the study involve?
Participants are asked to join this study at the time of their diagnosis. The study involves one MRI scan before and one after the anticancer treatment that is given before surgery. The first scan is used instead of the routine method used today (PET-CT) and the second scan is added for the purpose of this study. The scan takes around 60-90 minutes and involves lying on your back in a small space.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. In the future, we hope to be able to use the knowledge gained from this study to formulate new strategies to improve patient survival and quality of life.
Where is the study run from?
This study is run from the Department of Surgical Sciences at Uppsala University Hospital, Uppsala, Sweden.
When is the study starting and how long is it expected to run for?
September 2018 to 2025.
Who is funding the study?
The Swedish Cancer Society (Cancerfonden)
Lions Cancer Fund Uppsala
Swedish Government Grants (ALF)
Who is the main contact?
Jakob Hedberg
Jakob.hedberg@surgsci.uu.se
Contact information
Scientific
Department of Surgical Sciences
Ing 70
Uppsala University Hospital
Uppsala
75185
Sweden
| Phone | +46 (0)186116507 |
|---|---|
| jakob.hedberg@surgsci.uu.se |
Study information
| Study design | We aim to evaluate PET-MRI in a cross-sectional cohort of patients planned for neaodjuvant treatment followed by resectional surgery for esophageal cancer and cancer of the gastroesophageal junction. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | PET-MRI for prediction of treatment response to neoadjuvant treatment of cancer in the esophagus and the gastroesophageal junction |
| Study acronym | PREciSE II (Pet magnetic RESonance of Esophagus II) |
| Study objectives | PET-MRI can combine data from PET with radiomic characteristics of the tumor in order to improve the prediction of complete pathological response to neoadjuvant treatment in esophageal cancer and cancer in the gastroesophageal junction. |
| Ethics approval(s) | Regional ethics review board Uppsala, 10/07/2018, ref: 2018/226 |
| Health condition(s) or problem(s) studied | Esophageal cancer and cancer in the gastroesophageal junction. |
| Intervention | The recruited patient undergoes a PET-MRI at diagnosis and one before surgery. This is a 60- to 90-minute investigation. The surgical specimen is investigated according to clinical routine for TNM (tumour, node metastasis) staging and tumor regression grade according to Becker. The follow up is performed in accordance with clinical routine. After that the patient is followed in our national registries for registration of death and up to 5-year survival rates can be included in future analyses. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The main outcome measure is specificity and sensitivity for prediction of complete pathological response to neoadjuvant treatment. The radiomic results will be calculated by an operated blinded for other clinical data and the score will be entered into a dataset. Other radiologic markers (SUV-max etc) will be entered as well. The pathological examination will also be entered into a blinded dataset and correlation analyses will be performed. |
| Secondary outcome measures | Tumor immune cell population composition in relation to pathological clinical response. Plasma and tumor samples before and after neoadjuvant therapy are frozen and saved for future analysis. In circulating plasma, biomarker assays will be preformed before, during and after neoadjuvant treatment along with appropriate bioinformatic statistical interpretation (Oling, Immunooncology panel). In addition to this, immunohistochemical analyses of tumour material (CD4, FoxP3, CD8/CD45RO andEn CD20), analyses for immunology gene-expression before and after neoadjuvant treatment (Nanostring, nCounter Immunology ans Inflammation panels) will be performed. |
| Overall study start date | 01/01/2018 |
| Completion date | 31/12/2025 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 patients |
| Key inclusion criteria | 1. Aged over 18 years 2. Esophageal cancer or gastroesophageal junctional cancer Siewert I and II 3. Planned for neoadjuvant treatment and surgery 4. Clinical stage T1-4aN0-3M0 |
| Key exclusion criteria | 1. Cannot undergo MRI due to claustrophobia 2. Implants contraindicating MRI fitted, including pacemaker, pacemaker electrodes, mechanical heart valve, CNS electrodes and cochlear implants 3. Language difficulties making informed consent impossible 4. Renal failure 5. Allergy to contrast medium 6. Pregnancy |
| Date of first enrolment | 01/09/2018 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- Sweden
Study participating centre
75185
Uppsala
75185
Sweden
Sponsor information
University/education
Department of Surgical Sciences
Uppsala University Hospital
Uppsala
75185
Sweden
| Website | https://www.surgsci.uu.se/?languageId=1 |
|---|---|
"ROR" |
https://ror.org/048a87296 |
Funders
Funder type
Charity
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Cancer Society
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal with the first results (main outcome) in 2021 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to Swedish law prohibiting unspecified dissemination of patient-related data or images even if anonymised. |
Editorial Notes
01/03/2021: This study is no longer open for inclusion due to a lack of radiological expertise and funding.
23/04/2020: Due to current public health guidance, recruitment for this study has been paused.
18/07/2018: Ethics approval details added.
