Primary esophageal cancer
Conditions
Interventions
Product Name: CER-001
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ApoA-I
Current Sponsor code: CER-001
Other descriptive name: APOLIPOPROTEIN A-I, HUMAN
Concentration unit: mg/ml m
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
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 |
|---|---|
| Main Objective: To assess the tumor uptake of 89Zr-labeled CER-001;Secondary Objective: To evaluate the biodistribution of 89Zr-labeled CER-001 To evaluate the correlation between 89Zr-labeled CER-001 and tumor microcirculation as assessed with Dynamic Contrast Enhanced-MRI (DCE-MRI) and Diffusion Weighted Imaging/Intravoxel Incoherend Motion (DWI/IVIM) MRI To evaluate whether histological markers of the tumor biopsy correlate with 89Zr- PET signal and MRI parameters ;Primary end point(s): The main parameter to study will be percent injected dose per gram (%ID/g) of the tumor.;Timepoint(s) of evaluation of this end point: PET/CT scanning will be performed at 1 hour, 24 hours and 72 hours after injection of 89Zr-labeled CER-001. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objective of this study is to evaluate the biodistribution of 89Zr-labeled CER-001. To study this, the uptake of 89Zr-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 89Zr-labeled CER-001. In addition, we will evaluate the correlation between histological markers from the biopsy material from the tumor and 89Zr-PET signal and MRI parameters.;Timepoint(s) of evaluation of this end point: PET/CT scanning will be performed at 1 hour, 24 hours and 72 hours after injection of 89Zr-labeled CER-001. MRI will be performed at baseline. | — |
Countries
Netherlands
Contacts
Public ContactVasc.Med. Clinical Trial Unit
Academic Medical Center
Outcome results
None listed