esophageal cancer gullet cancer
Conditions
Interventions
esophageal cancer
nanomedicine
PET/CT
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Adult patients (either gender) older than 18 years - Clinical diagnosis of primary esophageal cancer
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Any treatment that could interfere with the conduct or interpretation of the study in the opinion of the investigator - Any clinically relevant condition that could interfere with the conduct of the study in the opinion of the investigator - Standard contra-indications to PET, CT or MRI - Inability or unwilling to comply with protocol requirements, or deemed by the investigator to have a disorder that may compromise the ability to give informed consent and/or to comply with all required study procedures and visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective is to assess the tumor uptake of Zr89-labeled CER-001 in patients with esophageal cancer. The main parameter to study will be percent injected dose per gram (%ID/g) of the tumor. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to evaluate the biodistribution of 89Zr-labeled CER-001. To study this, the uptake of Zr89-labeled CER-001 expressed as %ID/g in different organs will be determined. We will evaluate the tumor microcirculation using DCE-MRI and DWI/IVIM MRI and study whether MRI parameters are correlated to tumor uptake of Zr89-labeled CER-001. In addition, we will evaluate the correlation between histological markers from the biopsy material from the tumor and Zr89-PET signal and MRI parameters. | — |
Countries
The Netherlands
Outcome results
None listed