Rectal CancerPhase 1/2MIRCA & MIPACNCT06395337
Multimodal Imaging in Rectal Cancer & Pancreatic Cancer
A Phase 1/2 study testing [111In]In-DOTA-ANTI-CEA antibody injection, SPECT/CT scan and Resection surgery in people with Rectal Cancer and Pancreatic Cancer, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Pancreatic Cancer
- What is being tested?
- [111In]In-DOTA-ANTI-CEA antibody injection, SPECT/CT scan and Resection surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- 2 May 2024to 2 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Leiden University Medical Center
Leiden, 2333 ZA
Alexander Vahrmeijer, MD, PhD
Alexander Vahrmeijer, MD, PhD
Radboudumc
Nijmegen, 6525 GA
Aaya Darai, MD
JHW de Wilt, MD, PhD
About this study
Official title: 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
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
- Rectal Cancer, Pancreatic Cancer
- Being tested
- [111In]In-DOTA-ANTI-CEA antibody injection, SPECT/CT scan, Resection surgery
- Medical subject headings
- Rectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[111In]In-DOTA-ANTI-CEA antibody injectionDrug
tracer injection
SPECT/CT scanRadiation
abdominal and thoracic SPECT/CT scan
Resection surgeryProcedure or surgery
oncological resection surgery will be performed extended with the use of dual-modality imaging.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [111In]In-DOTA-ANTI-CEA antibody injection; Radiation: SPECT/CT scan; Procedure: Resection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (5)
Intensity of fluorescence
To assess the intensity of fluorescence in malignant and non-malignant tissue, using quantifiable images
Measured: 7 days
Intensity of radiosignal
To assess the intensity of the radiosignal in malignant and non-malignant tissue, using radioactive measuring device.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start2 May 2024 (estimated)
- Primary completion2 May 2025 (estimated)
- Study completion2 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395337
- Sponsor's protocol ID
- ORG-100023234
- Acronym
- MIRCA & MIPAC
- Status last verified
- Jul 2023
- First submitted
- 9 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06395337
- Acronym / sponsor ID
- MIRCA & MIPAC / ORG-100023234
- Conditions
- Rectal Cancer, Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 2 May 2024 (estimated)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- 2 Jun 2025 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative multi-modality imaging | Experimental | Drug: [111In]In-DOTA-ANTI-CEA antibody injection, Radiation: SPECT/CT scan, Procedure: Resection surgeryPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [111In]In-DOTA-ANTI-CEA antibody injectiontracer injection | Drug | Intraoperative multi-modality imaging |
| SPECT/CT scanabdominal and thoracic SPECT/CT scan | Radiation | Intraoperative multi-modality imaging |
| Resection surgeryoncological resection surgery will be performed extended with the use of dual-modality imaging. | Procedure or surgery | Intraoperative multi-modality imaging |
Primary outcome
Safety of dual-labeled antibody as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0
Time frame: 30 days
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
5 secondary outcomes
Intensity of fluorescence
Time frame: 7 days
Intensity of radiosignal
Time frame: 7 days
Concordance between CEA and tracer
Time frame: 7 days
Blood levels of the dual-labeled antibody
Time frame: 30, 60, 120, 180 minutes
Biodistribution
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [111In]In-DOTA-ANTI-CEA antibody injection, SPECT/CT scan and Resection surgery in people with Rectal Cancer and Pancreatic Cancer, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aaya Darai, MD (0031634251046, aaya.darai@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.