Main objective:- To assess the tumor uptake of Zr89-labeled CER-001 (% injected dose/gram)Secondary objectives:- To evaluate the biodistribution of Z89r-labeled CER-001- To evaluate the correlation between Zr89-labeled CER-001 and tumor…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Recent pre-clinical studies have demonstrated that reconstituted radio-labeled
HDL nanoparticles may be used for Zr89-PET imaging of tumors, with specificity
for tumor associated macrophages. In cancer patients, Zr89-labeling of the HDL
mimetic CER-001 allows for non-invasive evaluation of the potential of HDL
nanomedicinal strategies in esophageal cancer.
Study objective
Main objective:
- To assess the tumor uptake of Zr89-labeled CER-001 (% injected dose/gram)
Secondary objectives:
- To evaluate the biodistribution of Z89r-labeled CER-001
- To evaluate the correlation between Zr89-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
Zr89- PET signal and MRI parameters
Study design
This study is designed as a single-center observational study. Patients with
pathologically confirmed esophageal cancer will be included for this study and
visit the study center three times.
Study burden and risks
The results of this study contribute to the development of novel imaging and
therapeutic approaches to ultimately reduce morbidity and mortality in cancer.
Considering the poor prognosis in certain cancer types such as esophageal
cancer, clinically establishing the nanodelivery paradigm using HDL particles
may have great implications for these diseases. HDL particles are endogenous
carrier vehicles, and may be exploited to deliver chemotherapeutic agents to
tumors, thereby increasing efficacy by higher drug delivery to the area of
interest, with fewer systemic side effects due to the targeted delivery and
lower cumulative dose. We envision that the use of HDL nanoparticles offers a
theranostic approach, as it adds to the therapeutic arsenal of treatments, and
may also be a means to select suitable patients to allow for personalized
treatment.
In the present study, participating subjects receive no direct or immediate
benefits. The burden and risk of participating in this study is estimated to be
low. Patients will visit the clinical trial unit three times, with a total
duration of 300 minutes. Over three visits, a total of 30 ml of blood will be
drawn. There are no direct toxic effects associated with the administration of
Zr89-labeled CER-001, except for the risks associated with radiation exposure.
The maximum exposure related to PET/CT scanning is 41.2 mSv in this study.
However, patients included in this study have diagnosed esophageal cancer
conferring a poor prognosis and will undergo radiation therapy, making it
unlikely that the radiation exposure in this study is relevant. The potential
benefits of developing HDL nanotherapy for cancer is expected to compensate for
the radiation risk. In addition, this study is relevant for a much larger group
of cancer patients, who will not have to be exposed to these risks due to this
study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-000724-10-NL |
| CCMO | NL60978.018.17 |