Pancreatic Cancer, Rectal Cancer
Conditions
Brief summary
Most digestive cancers show (over)expression of the tumour marker carcinoembryonic antigen (CEA). Therefore, interest in CEA-targeting tracers has increased over the past years. CEA-targeting tracers can be used for preoperative, intra-operative and postoperative imaging purposes. This study focusses on both preoperative and intraoperative multimodal imaging and image-guided surgery in patients with rectal cancer or pancreatic cancer.
Interventions
DRUG[111In]In-DOTA-ANTI-CEA antibody injection
tracer injection
RADIATIONSPECT/CT scan
abdominal and thoracic SPECT/CT scan
PROCEDUREResection surgery
oncological resection surgery will be performed extended with the use of dual-modality imaging.
Sponsors
Leiden University Medical Center
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of rectal cancer where a (beyond) TME resection is planned for OR Clinical suspicion of PDAC * Scheduled for surgical resection * Age over 18 years * Signed informed consent
Exclusion criteria
* Any medical condition present that in the opinion of the investigator will affect patients' clinical status * Administration of a radionuclide within 10 physical half-lives prior to study enrollment * Pregnancy or lactation * Known CEA negative tumor: If a patient had a primary tumor which did not express CEA determined immunohistochemically on the resection specimen of a prior operation or biopsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of dual-labeled antibody as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0 | 30 days | Safety of dual-labeled antibody injection as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution | 7 days | To determine the whole body biodistribution of the tracer over time by quantified SPECT/CT imaging at 2 timepoints. |
| Intensity of fluorescence | 7 days | To assess the intensity of fluorescence in malignant and non-malignant tissue, using quantifiable images |
| Intensity of radiosignal | 7 days | To assess the intensity of the radiosignal in malignant and non-malignant tissue, using radioactive measuring device. |
| Concordance between CEA and tracer | 7 days | To assess the concordance between localization of the \[111In\]In-ANTI-CEA and CEA expression in rectal or pancreatic cancer and non-malignant tissue, by analyzing pathologic tissue for tracer activity and CEA presentation |
| Blood levels of the dual-labeled antibody | 30, 60, 120, 180 minutes | To determine blood concentrations at several time points in patients to assess the pharmacokinetics of the tracer. |
Countries
Netherlands
Contacts
Primary ContactAaya Darai, MD
Outcome results
None listed