Multimodal Imaging in Rectal Cancer & Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-02

Study Completion Date

2025-06-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Rectal Cancer Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

tracer injection

SPECT/CT scan

Intervention Type RADIATION

abdominal and thoracic SPECT/CT scan

Resection surgery

Intervention Type PROCEDURE

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

Interventions

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

tracer injection

Intervention Type DRUG

SPECT/CT scan

abdominal and thoracic SPECT/CT scan

Intervention Type RADIATION

Resection surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No