Targeting esophageal cancer with HDL nanoparticles: an imaging study<br>

Phase 2

Completed

• Conditions: esophageal cancer; gullet cancer; 10017991

• Registration Number: NL-OMON45362
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-06-14
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

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

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: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main objective is to assess the tumor uptake of Zr89-labeled CER-001 in<br /><br>patients with esophageal cancer. The main parameter to study will be percent<br /><br>injected dose per gram (%ID/g) of the tumor.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective of this study is to evaluate the biodistribution of<br /><br>89Zr-labeled CER-001. To study this, the uptake of Zr89-labeled CER-001<br /><br>expressed as %ID/g in different organs will be determined.<br /><br><br /><br>We will evaluate the tumor microcirculation using DCE-MRI and DWI/IVIM MRI and<br /><br>study whether MRI parameters are correlated to tumor uptake of Zr89-labeled<br /><br>CER-001. In addition, we will evaluate the correlation between histological<br /><br>markers from the biopsy material from the tumor and Zr89-PET signal and MRI<br /><br>parameters.</p><br>