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2024-05-02
2025-05-02
2025-06-02
20
NCT06395337
Radboud University Medical Center
Radboud University Medical Center
INTERVENTIONAL
Multimodal Imaging in Rectal Cancer & 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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-04-09 | N/A | 2024-04-29 |
2024-04-29 | N/A | 2024-05-02 |
2024-05-02 | N/A | 2023-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
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 | DRUG: [111In]In-DOTA-ANTI-CEA antibody injection
RADIATION: SPECT/CT scan
PROCEDURE: Resection surgery
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Aaya Darai, MD Phone Number: 0031634251046 Email: aaya.darai@radboudumc.nl |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
