Using MRI to predict the success of anticancer treatment before surgery to the esophagus (gullet) and the gastroesophageal junction (gullet-stomach junction)

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN35827514

Enrollment

Registered

2018-05-22

Start date

2018-09-01

Completion date

Unknown

Last updated

2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer and cancer in the gastroesophageal junction. Cancer Esophagus cancer, gastro-esophageal junction cancer

Interventions

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 (tu

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026