Multimodal Imaging in Rectal Cancer & Pancreatic Cancer (MIRCA & MIPAC)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer; Rectal Cancer
• Intervention / Treatment: Drug: [111In]In-DOTA-ANTI-CEA antibody injection; Radiation: SPECT/CT scan; Procedure: Resection surgery

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Aaya Darai, MD; Phone Number: 0031634251046; Email: aaya.darai@radboudumc.nl

Study Locations

• Netherlands
  • Leiden, Netherlands, 2333 ZA
    • Leiden University Medical Center
    • Principal Investigator: Alexander Vahrmeijer, MD, PhD
    • Contact: Alexander Vahrmeijer, MD, PhD
  • Nijmegen, Netherlands, 6525 GA
    • Radboudumc
    • Contact: Aaya Darai, MD
    • Principal Investigator: JHW de Wilt, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoperative multi-modality imaging; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of fluorescence	To assess the intensity of fluorescence in malignant and non-malignant tissue, using quantifiable images	7 days
Intensity of radiosignal	To assess the intensity of the radiosignal in malignant and non-malignant tissue, using radioactive measuring device.	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	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.	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.	7 days

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2024
• Primary Completion (Estimated): May 2, 2025
• Study Completion (Estimated): June 2, 2025

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Pancreatic Diseases; Rectal Neoplasms; Pancreatic Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: ORG-100023234

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No