Multimodal Imaging in Rectal Cancer & Pancreatic Cancer
MIRCA & MIPAC
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
1 other identifier
interventional
20
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2024
CompletedFirst Posted
Study publicly available on registry
May 2, 2024
CompletedStudy Start
First participant enrolled
May 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2025
CompletedMay 2, 2024
July 1, 2023
1 year
April 9, 2024
April 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Intensity of fluorescence
7 days
Intensity of radiosignal
7 days
Concordance between CEA and tracer
7 days
Blood levels of the dual-labeled antibody
30, 60, 120, 180 minutes
Biodistribution
7 days
Study Arms (1)
Intraoperative multi-modality imaging
EXPERIMENTALPatients 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.
Interventions
oncological resection surgery will be performed extended with the use of dual-modality imaging.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Leiden University Medical Center
Leiden, 2333 ZA, Netherlands
Radboudumc
Nijmegen, 6525 GA, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2024
First Posted
May 2, 2024
Study Start
May 2, 2024
Primary Completion
May 2, 2025
Study Completion
June 2, 2025
Last Updated
May 2, 2024
Record last verified: 2023-07