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| Name | Class |
|---|---|
| Leiden University Medical Center | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative multi-modality imaging | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [111In]In-DOTA-ANTI-CEA antibody injection | Drug | tracer injection |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aaya Darai, MD | Contact | 0031634251046 | aaya.darai@radboudumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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| SPECT/CT scan |
| Radiation |
abdominal and thoracic SPECT/CT scan |
|
| Resection surgery | Procedure | oncological resection surgery will be performed extended with the use of dual-modality imaging. |
|
| 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 |
| Radboudumc | Nijmegen | 6525 GA | Netherlands |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |