Multimodal Imaging in Rectal Cancer & Pancreatic Cancer

Radboud University Medical Center20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Rectal Cancer Pancreatic Cancer

Interventions

[111In]In-DOTA-ANTI-CEA antibody injectionDRUG

tracer injection

SPECT/CT scanRADIATION

abdominal and thoracic SPECT/CT scan

Resection surgeryPROCEDURE

oncological resection surgery will be performed extended with the use of dual-modality imaging.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Leiden University Medical Center

Leiden, Netherlands

Radboudumc

Nijmegen, Netherlands

Outcomes

Primary Outcomes

Safety of dual-labeled antibody as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0

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

Time frame: 30 days

Secondary Outcomes

Intensity of fluorescence

To assess the intensity of fluorescence in malignant and non-malignant tissue, using quantifiable images

Time frame: 7 days

Intensity of radiosignal

To assess the intensity of the radiosignal in malignant and non-malignant tissue, using radioactive measuring device.

Time frame: 7 days

Concordance between CEA and tracer

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

Time frame: 7 days

Blood levels of the dual-labeled antibody

To determine blood concentrations at several time points in patients to assess the pharmacokinetics of the tracer.

Time frame: 30, 60, 120, 180 minutes

Biodistribution

To determine the whole body biodistribution of the tracer over time by quantified SPECT/CT imaging at 2 timepoints.

Time frame: 7 days

Central Contacts

Aaya Darai, MD

CONTACT

0031634251046 aaya.darai@radboudumc.nl

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.