Colon CarcinomaDETOURNCT06008522
Safety and Feasibility of Immuno-OCT
A study testing Bevacizumab-800CW in people with Colon Carcinoma and Barrett Esophagus, run by University Medical Center Groningen.
Trial summary
To improve detection of premalignant lesions in the gastrointestinal tract (the rectum and the esophagus) there is a need for better endoscopic visualization and the ability for targeted biopsies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Carcinoma, Barrett Esophagus, Gastrointestinal Dysplasia
- What is being tested?
- Bevacizumab-800CW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Mar 2025
- Phase
- Interventional
- 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
- Indication for a therapeutic endoscopy procedure (EMR or ESD);
- Age ≥ 18;
- Written informed consent.
Who cannot join
- Patients younger than 18 years old;
- Submucosal and invasive esophageal adenocarcinoma (EAC) or colorectal carcinoma (CRC);
- Radiation therapy for esophageal or colorectal cancer;
- History of infusion reactions to Bevacizumab or other monoclonal antibodies;
- Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer;
- Non-adjustable hypertension;
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
- Pregnancy or breastfeeding; a negative pregnancy test must be available for women of childbearing potential.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Determining the Safety and Feasibility of Optical Coherence Tomography and Near Infrared Fluorescence: a Prospective Pilot Intervention Study
To improve detection of premalignant lesions in the gastrointestinal tract (the rectum and the esophagus) there is a need for better endoscopic visualization and the ability for targeted biopsies. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labelling the VEGF-A-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye bevacizumab-800CW (IRDye800CW). In several phase I studies and phase II studies, either completed or currently running, in the UMCG, the use of VEGF-A-guided near-infrared (NIR) fluorescence molecular endoscopy (FME) in combination with high-definition white light endoscopy (HD-WLE) shows an improved detection rate of early premalignant lesions. In this study the safety and feasibility of a next generation imaging system will be tested. This system uses immune optical coherence tomography (immuno-OCT) and near infrared fluorescence (NIRF) with the targeted tracer (Bevacizumab-800CW) for improvement of the detection of dysplastic lesions in Barret's esophagus (BE) and colorectal polyp detection. The system provides more depth information and can eventually be used without the guidance of the regular endoscopy system.
- Being tested
- Bevacizumab-800CW
- Keywords
- optical coherence tomography
- Medical subject headings
- Colonic Neoplasms, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab-800CWDrug
Also called OCT imaging
Imaging of fluorescently labeled Bevacizumab-800CW using OCT.
| Study group | Role | What they receive |
|---|---|---|
| OCT with IV in colorectal polyps | Experimental | OCT and FME imaging of Barret and colorectal lesions during endoscopy. Receives: Drug: Bevacizumab-800CW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Device-related Events (ADEs) and Serious Adverse Device-related Events (SADEs) using immuno-OCT
Any events related to the device.
Measured: during procedure
Secondary outcomes (4)
Validation of the immuno-OCT system: FME
Validation of the immuno-OCT endoscopy results compared to fluorescence seen in FME imaging results.
Measured: During procedure
Validation of OCT system: Ex vivo fluorescence imaging
Validation of the immuno-OCT endoscopy results compared to the correlation of ex vivo fluorescent signals to histopathological analysis results.
Measured: During procedure
validation of OCT system: ex vivo immuno-OCT imaging
Validation of the immuno-OCT endoscopy results compared to the correlation of in vivo and ex vivo immuno-OCT imaging to histopathological analysis results.
Measured: During procedure
validation of OCT system: immunohistochemistry
Validation of the in vivo immune-OCT endoscopy results by comparing it to histopathological analysis results.
Measured: Once, as soon as possible after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Apr 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CarcinomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- W.B. Nagengast, MD, PhD, PharmD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008522
- Sponsor's protocol ID
- 11258
- Acronym
- DETOUR
- Status last verified
- Mar 2024
- First submitted
- 15 Jun 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Safety and Feasibility of Optical Coherence Tomography and Near Infrared Fluorescence: a Prospective Pilot Intervention Study
- ClinicalTrials.gov ID
- NCT06008522
- Acronym / sponsor ID
- DETOUR / 11258
- Keywords
- optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 23 Aug 2023 (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.
To improve detection of premalignant lesions in the gastrointestinal tract (the rectum and the esophagus) there is a need for better endoscopic visualization and the ability for targeted biopsies. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labelling the VEGF-A-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye bevacizumab-800CW (IRDye800CW). In several phase I studies and phase II studies, either completed or currently running, in the UMCG, the use of VEGF-A-guided near-infrared (NIR) fluorescence molecular endoscopy (FME) in combination with high-definition white light endoscopy (HD-WLE) shows an improved detection rate of early premalignant lesions. In this study the safety and feasibility of a next generation imaging system will be tested. This system uses immune optical coherence tomography (immuno-OCT) and near infrared fluorescence (NIRF) with the targeted tracer (Bevacizumab-800CW) for improvement of the detection of dysplastic lesions in Barret's esophagus (BE) and colorectal polyp detection. The system provides more depth information and can eventually be used without the guidance of the regular endoscopy system.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT with IV in colorectal polyps | Experimental | Drug: Bevacizumab-800CWOCT and FME imaging of Barret and colorectal lesions during endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for a therapeutic endoscopy procedure (EMR or ESD);
- Age ≥ 18;
- Written informed consent.
Key exclusion criteria (8 listed)
- Patients younger than 18 years old;
- Submucosal and invasive esophageal adenocarcinoma (EAC) or colorectal carcinoma (CRC);
- Radiation therapy for esophageal or colorectal cancer;
- History of infusion reactions to Bevacizumab or other monoclonal antibodies;
- Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer;
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 |
|---|---|---|
| Bevacizumab-800CWAlso: OCT imagingImaging of fluorescently labeled Bevacizumab-800CW using OCT. | Drug | OCT with IV in colorectal polyps |
Primary outcome
Number of Adverse Device-related Events (ADEs) and Serious Adverse Device-related Events (SADEs) using immuno-OCT
Time frame: during procedure
Any events related to the device.
4 secondary outcomes
Validation of the immuno-OCT system: FME
Time frame: During procedure
Validation of OCT system: Ex vivo fluorescence imaging
Time frame: During procedure
validation of OCT system: ex vivo immuno-OCT imaging
Time frame: During procedure
validation of OCT system: immunohistochemistry
Time frame: Once, as soon as possible after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Colon Carcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
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.
W.B. Nagengast, MD, PhD, PharmD principal investigator
University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
A study testing Bevacizumab-800CW in people with Colon Carcinoma and Barrett Esophagus, run by University Medical Center Groningen.
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 3 inclusion and 8 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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 W.B. Nagengast, MD, PhD, PharmD (+31503612620, w.b.nagengast@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Device-related Events (ADEs) and Serious Adverse Device-related Events (SADEs) using immuno-OCT (time frame: during procedure). 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 20 Mar 2024.