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

Radboud University Medical Center

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Pancreatic Cancer; Rectal Cancer

Treatments: Procedure: Resection surgery; Radiation: SPECT/CT scan; Drug: [111In]In-DOTA-ANTI-CEA antibody injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06395337

ORG-100023234

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intraoperative multi-modality imaging

Experimental group

Description:

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.

Treatment:

Procedure: Resection surgery

Radiation: SPECT/CT scan

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