GlioblastomaPhase 1MIRRORNCT05929456
Multispectral Bimodal Fluorescence Guided Surgery of High-grade Glioma With Cetuximab-800CW and 5-ALA (5-aminolevulinic Acid)
A Phase 1 study testing Cetuximab-IRDye800 in people with Glioblastoma and High-grade Glioma, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The MIRROR study is a prospective, single center phase I feasibility and dose finding study in patients with high-grade glioma, to establish the safety, feasibility, and optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery, in comparison to the standard of care (SOC), 5-ALA fluorescent imaging agent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, High-grade Glioma
- What is being tested?
- Cetuximab-IRDye800
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 May 2023to 1 Jan 2025
- Phase
- Phase 1
- 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
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
- Capable of giving signed informed consent (voluntarily), indicating that the patient understands the purpose and procedures required for the study and is willing to comply with the requirements and restrictions listed in the informed consent form and in this protocol.
- Patients aged ≥ 18 years inclusive at moment signing informed consent form.
- Established high-grade glioma (glioblastoma, grade 4 according to the WHO (World Health Organization) classification) and scheduled for surgical intervention.
- Life expectancy of > 12 weeks.
- Karnofsky performance status of at least 70%.
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- No clinically significant laboratory abnormalities as determined by the investigator
- o Note: one retest of lab tests is allowed within the screening window
- Female patients should fulfil one of the following criteria:
- At least 1 year post-menopausal (amenorrhea >12 months) at screening
- Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation)
- Women >18 years of age who are fertile, need to agree to use an adequate form of contraceptives during and till 3 months after the study. Before study enrollment, a pregnancy test in blood or urine will be performed to rule out a pregnancy. In the case of an unlikely pregnancy during the study, they accept the possible maternal/ fetal risk of participation in the study.
Who cannot join
- General:
- Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the patient to understand and cooperate with the study protocol
- Deprived of freedom by an administrative or court order or in an emergency setting.
- Insufficient venous access for the study procedures.
- Close affiliation with the investigator; e.g. a close relative of the investigator, dependent person (e.g. employee or student), employee of the department of Neurosurgery of the UMCG (University Medical Center Groningen), or affiliates
- Any finding in the medical examinations or medical history giving, that in the opinion of the investigator, leads to a reasonable suspicion of a disease or condition that makes treatment with the investigational drug unadvisable, or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications
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- Participation in an interventional clinical study within 30 days prior to tracer administration that involved treatment with any drug (excluding vitamins and minerals) or medical device
- Medical conditions
- Concomitant malignancies, including metastasized colon-, rectal-, breast carcinoma, non-small cellular lung carcinoma (NSCLC); primary epithelial ovarian-, fallopian tube-, primary peritoneal- or cervical carcinoma.
- Any abnormalities in the vital signs of the patient, as judged by the investigator, as a result of which the patient cannot participate
- eGFR (based on plasma-creatinine) outside of normal range at screening or known renal impairment (≤40 mL/min).
- Current evidence or history of bacterial, viral or fungal infections within 7 days before Cetuximab-IRDye800CW administration, as judged by the Investigator.
- o T > = 38.0°C or lab confirmed viral/bacterial/fungal infection (PCR)) or symptoms suggestive of an infection)
- Any laboratory test which is abnormal, and which is deemed by the Investigator(s) to be clinically significant
- A history of anaphylaxis, history of allergic reaction(s), known allergy to one of the drugs or excipients administered as part of this study. Mild allergies without angioedema or treatment need can be acceptable if deemed not to be of clinical significance (including but not limited to allergy to animals or mild seasonal hay fever)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMCG
Groningen, 9700RB
Yester Janssen, MD, +31615170900, y.f.janssen@umcg.nl
About this study
Official title: Multispectral and Bimodal Fluorescent Guided Surgery (FGS) of High-grade Glioma for Refining Margin Assessment: A Phase 1 Dose Finding Study Using Cetuximab-IRDye800CW Combined With 5-ALA.
The MIRROR study is a prospective, single center phase I feasibility and dose finding study in patients with high-grade glioma, to establish the safety, feasibility, and optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery, in comparison to the standard of care (SOC), 5-ALA fluorescent imaging agent. The main research objectives of this study are:
- To determine the optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery
- To assess the safety and tolerability
- To correlate fluorescent signals measured by in vivo multispectral imaging with Cetuximab-IRDye800CW and 5-ALA with those measured by ex vivo imaging
The study population will consist of patients, aged ≥18 years, diagnosed with high-grade glioma and scheduled for surgery.
- Conditions
- Glioblastoma, High-grade Glioma
- Being tested
- Cetuximab-IRDye800
- Keywords
- Fluorescence guided surgery, Glioblastoma, High-grade glioma, 5-ALA
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab-IRDye800Drug
patients will receive a single IV injection of Cetuximab-IRDye800CW 2-4 days prior to surgert. The IMP (Investigational medicinal product)/tracer will be used for fluorescence guided surgery.
| Study group | Role | What they receive |
|---|---|---|
| Glioblastoma group | Experimental | This study will consist of 1 group and therefore 1 arm Receives: Drug: Cetuximab-IRDye800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal dosage
To determine the optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery of high-grade glioma using Near- Infrared (NIR) fluorescence imaging
Measured: 1 day
To assess the safety and tolerability of intravenous tracer administration by measuring/registering the number(S)AEs and SUSARs that have occurred during the duration of the trial
The (S)AEs and SUSARS will be reported according to the CTCAE v4.0
Measured: 4-5 days
In vivo/ex vivo correlation
To correlate fluorescent signals measured by in vivo multispectral imaging with Cetuximab-IRDye800CW and 5-ALA with those measured by ex vivo imaging
Measured: 1 day
Secondary outcomes (2)
Fluorescent signals vs pathology
To correlate the presence of pathologically confirmed EGFR(epidermal growth factor receptor)-gene amplification with the presence of fluorescence signals, in- and ex vivo, as measured with NIR fluorescent imaging after administering Cetuximab-IRDye800CW.
Measured: 1 day
DSC biomarkers
Correlation between DSC (dynamic susceptibility contrast) biomarkers with pathological EGFR-gene amplification status.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start5 May 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, single center phase I feasibility and dose finding study in a single cohort, i.e patients with glioblastoma
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob Groen, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929456
- Sponsor's protocol ID
- NC2022-01
- Acronym
- MIRROR
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon request it can be decided whether data will/can be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multispectral and Bimodal Fluorescent Guided Surgery (FGS) of High-grade Glioma for Refining Margin Assessment: A Phase 1 Dose Finding Study Using Cetuximab-IRDye800CW Combined With 5-ALA.
- ClinicalTrials.gov ID
- NCT05929456
- Acronym / sponsor ID
- MIRROR / NC2022-01
- Conditions
- Glioblastoma, High-grade Glioma
- Keywords
- Fluorescence guided surgery, Glioblastoma, High-grade glioma, 5-ALA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 3 Jul 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.
The MIRROR study is a prospective, single center phase I feasibility and dose finding study in patients with high-grade glioma, to establish the safety, feasibility, and optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery, in comparison to the standard of care (SOC), 5-ALA fluorescent imaging agent. The main research objectives of this study are:
- To determine the optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery
- To assess the safety and tolerability
- To correlate fluorescent signals measured by in vivo multispectral imaging with Cetuximab-IRDye800CW and 5-ALA with those measured by ex vivo imaging
The study population will consist of patients, aged ≥18 years, diagnosed with high-grade glioma and scheduled for surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, single center phase I feasibility and dose finding study in a single cohort, i.e patients with glioblastoma
| Arm | Type | Receives |
|---|---|---|
| Glioblastoma group | Experimental | Drug: Cetuximab-IRDye800This study will consist of 1 group and therefore 1 arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
- Capable of giving signed informed consent (voluntarily), indicating that the patient understands the purpose and procedures required for the study and is willing to comply with the requirements and restrictions listed in the informed consent form and in this protocol.
- Patients aged ≥ 18 years inclusive at moment signing informed consent form.
- Established high-grade glioma (glioblastoma, grade 4 according to the WHO (World Health Organization) classification) and scheduled for surgical intervention.
- Life expectancy of > 12 weeks.
Key exclusion criteria (15 listed)
- Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the patient to understand and cooperate with the study protocol
- Deprived of freedom by an administrative or court order or in an emergency setting.
- Insufficient venous access for the study procedures.
- Close affiliation with the investigator; e.g. a close relative of the investigator, dependent person (e.g. employee or student), employee of the department of Neurosurgery of the UMCG (University Medical Center Groningen), or affiliates
- Any finding in the medical examinations or medical history giving, that in the opinion of the investigator, leads to a reasonable suspicion of a disease or condition that makes treatment with the investigational drug unadvisable, or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications
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 |
|---|---|---|
| Cetuximab-IRDye800patients will receive a single IV injection of Cetuximab-IRDye800CW 2-4 days prior to surgert. The IMP (Investigational medicinal product)/tracer will be used for fluorescence guided surgery. | Drug | Glioblastoma group |
Primary outcome
Optimal dosage
Time frame: 1 day
To determine the optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery of high-grade glioma using Near- Infrared (NIR) fluorescence imaging
To assess the safety and tolerability of intravenous tracer administration by measuring/registering the number(S)AEs and SUSARs that have occurred during the duration of the trial
Time frame: 4-5 days
The (S)AEs and SUSARS will be reported according to the CTCAE v4.0
In vivo/ex vivo correlation
Time frame: 1 day
To correlate fluorescent signals measured by in vivo multispectral imaging with Cetuximab-IRDye800CW and 5-ALA with those measured by ex vivo imaging
2 secondary outcomes
Fluorescent signals vs pathology
Time frame: 1 day
DSC biomarkers
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: Undecided. upon request it can be decided whether data will/can be shared with other researchers
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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.
Rob Groen, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cetuximab-IRDye800 in people with Glioblastoma and High-grade Glioma, run by University Medical Center Groningen at 1 site 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 12 inclusion and 15 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 Yester Janssen, MD (+316 15 17 09 00, y.f.janssen@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal dosage (time frame: 1 day). The study lists 3 primary outcomes in all. 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 3 Jul 2023.