Condition category
Cancer
Date applied
08/05/2018
Date assigned
22/05/2018
Last edited
14/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jakob Hedberg

ORCID ID

Contact details

Department of Surgical Sciences
Ing 70
Uppsala University Hospital
Uppsala
75185
Sweden
+46186116507
jakob.hedberg@surgsci.uu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

PET-MRI for prediction of treatment response to neoadjuvant treatment of cancer in the esophagus and the gastroesophageal junction

Acronym

PREciSE II (Pet magnetic RESonance of Esophagus II)

Study hypothesis

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

Regional ethics review board Uppsala, applied 10/05/2018

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

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

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 trial start date

01/01/2018

Overall trial end date

31/12/2025

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 patients

Participant 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

Recruitment start date

01/09/2018

Recruitment end date

31/12/2020

Locations

Countries of recruitment

Sweden

Trial participating centre

Uppsala University Hospital
Ing 70 75185
Uppsala
75185
Sweden

Sponsor information

Organisation

Uppsala University

Sponsor details

Department of Surgical Sciences
Uppsala University Hospital
75185 Uppsala
Uppsala
75185
Sweden

Sponsor type

University/education

Website

https://www.surgsci.uu.se/?languageId=1

Funders

Funder type

Not defined

Funder name

Lions Foundation(Uppsla, Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cancerfonden

Alternative name(s)

Swedish Cancer Society

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal with the first results (main outcome) in 2021

IPD sharing statement
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.

Intention to publish date

31/12/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes