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Trial Title:
Multimodal Imaging in Rectal Cancer & Pancreatic Cancer
NCT ID:
NCT06395337
Condition:
Rectal Cancer
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Rectal Neoplasms
Antibodies
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[111In]In-DOTA-ANTI-CEA antibody injection
Description:
tracer injection
Arm group label:
Intraoperative multi-modality imaging
Intervention type:
Radiation
Intervention name:
SPECT/CT scan
Description:
abdominal and thoracic SPECT/CT scan
Arm group label:
Intraoperative multi-modality imaging
Intervention type:
Procedure
Intervention name:
Resection surgery
Description:
oncological resection surgery will be performed extended with the use of dual-modality
imaging.
Arm group label:
Intraoperative multi-modality imaging
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Zip:
2333 ZA
Country:
Netherlands
Contact:
Last name:
Alexander Vahrmeijer, MD, PhD
Investigator:
Last name:
Alexander Vahrmeijer, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Radboudumc
Address:
City:
Nijmegen
Zip:
6525 GA
Country:
Netherlands
Contact:
Last name:
Aaya Darai, MD
Investigator:
Last name:
JHW de Wilt, MD, PhD
Email:
Principal Investigator
Start date:
May 2, 2024
Completion date:
June 2, 2025
Lead sponsor:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
Leiden University Medical Center
Agency class:
Other
Source:
Radboud University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06395337
