Targeting esophageal cancer with HDL nanoparticles: an imaging study

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 13

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the tumor uptake of 89Zr-labeled CER-001;Secondary Objective: To evaluate the biodistribution of 89Zr-labeled CER-001<br>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<br>To evaluate whether histological markers of the tumor biopsy correlate with 89Zr- PET signal and MRI parameters<br>;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 Outcome Measures

Name	Time	Method
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.<br><br>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.