Multimodal Imaging in Rectal Cancer & Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— MIRCA & MIPAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06395337
• Other study ID #: ORG-100023234
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2, 2024
• Est. completion date: June 2, 2025

Study information

• Verified date: July 2023
• Source: Radboud University Medical Center
• Contact: Aaya Darai, MD
• Phone: 0031634251046
• Email: aaya.darai[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2, 2025
• Est. primary completion date: May 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• [111In]In-DOTA-ANTI-CEA antibody injection
tracer injection

Radiation:
• SPECT/CT scan
abdominal and thoracic SPECT/CT scan

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

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Radboudumc	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Secondary	Intensity of fluorescence	To assess the intensity of fluorescence in malignant and non-malignant tissue, using quantifiable images	7 days
Secondary	Intensity of radiosignal	To assess the intensity of the radiosignal in malignant and non-malignant tissue, using radioactive measuring device.	7 days
Secondary	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	7 days
Secondary	Blood levels of the dual-labeled antibody	To determine blood concentrations at several time points in patients to assess the pharmacokinetics of the tracer.	30, 60, 120, 180 minutes
Secondary	Biodistribution	To determine the whole body biodistribution of the tracer over time by quantified SPECT/CT imaging at 2 timepoints.	7 days