A Phase I/II Study to Evaluate the Safety and Feasibility of Multimodal Imaging Using a Dual-labeled Anti-CEA Antibody in Patients With Rectal or Pancreatic Cancer

Trial ID: NCT06395337

Interventional - Phase 1/2 - Unknown status

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.

Conditions

• Rectal Cancer
• Pancreatic Cancer

Interventions

• [111In]In-DOTA-ANTI-CEA antibody injection
• SPECT/CT scan
• Resection surgery

Eligibility

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.

Sponsor

Radboud University Medical Center, Leiden University Medical Center

Source: ClinicalTrials.gov

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