Multimodal Imaging in Rectal Cancer & Pancreatic Cancer
- Conditions
- Rectal CancerPancreatic Cancer
- Interventions
- Drug: [111In]In-DOTA-ANTI-CEA antibody injectionRadiation: SPECT/CT scanProcedure: Resection surgery
- Registration Number
- NCT06395337
- Lead Sponsor
- Radboud University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intraoperative multi-modality imaging Resection surgery Patients receive a single intravenous dose of \[111In\]In-DOTA-ANTI-CEA antibody. At day 4 or 5 after antibody injection a SPECT/CT scan will be acquired. At day 6 or 7 standard of care cytoreductive surgery will be performed. This will be extended with the use of dual-modality imaging. Intraoperative multi-modality imaging [111In]In-DOTA-ANTI-CEA antibody injection Patients receive a single intravenous dose of \[111In\]In-DOTA-ANTI-CEA antibody. At day 4 or 5 after antibody injection a SPECT/CT scan will be acquired. At day 6 or 7 standard of care cytoreductive surgery will be performed. This will be extended with the use of dual-modality imaging. Intraoperative multi-modality imaging SPECT/CT scan Patients receive a single intravenous dose of \[111In\]In-DOTA-ANTI-CEA antibody. At day 4 or 5 after antibody injection a SPECT/CT scan will be acquired. At day 6 or 7 standard of care cytoreductive surgery will be performed. This will be extended with the use of dual-modality imaging.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Biodistribution 7 days To determine the whole body biodistribution of the tracer over time by quantified SPECT/CT imaging at 2 timepoints.
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.
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
Trial Locations
- Locations (2)
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Radboudumc
🇳🇱Nijmegen, Netherlands