Clinical trial · Interventional
Multimodal Imaging in Rectal Cancer & Pancreatic Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [111In]In-DOTA-ANTI-CEA antibody injection | Drug | — | UNRESOLVED |
| Resection surgery | Procedure | — | UNRESOLVED |
| SPECT/CT scan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative multi-modality imaging
- 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.
- interventionNames
- Drug: [111In]In-DOTA-ANTI-CEA antibody injection
- Radiation: SPECT/CT scan
- Procedure: Resection surgery
Primary outcomes (1)
- measure
- Safety of dual-labeled antibody as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0
- timeFrame
- 30 days
- description
- 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
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available