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. (*MIRROR study*)
- Conditions
- High-grade glioma10029211
- Registration Number
- NL-OMON53583
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 21
- 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 (astrocytoma grade 4 according to the WHO
classification) and scheduled for surgical intervention.
- Life expectancy of > 12 weeks.
- Karnofsky performance status of at least 70%.
- 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:
o At least 1 year post-menopausal (amenorrhea >12 months) at screening
o Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation)
o 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.
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, 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
- 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 angio-edema 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are to establish the safety, feasibility, and optimal<br /><br>dosage of Cetuximab-IRDye800CW for fluorescence guided surgery, in comparison<br /><br>to the standard of care (SOC), 5-ALA fluorescent imaging agent.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The identification of DSC MR imaging biomarkers predictive for EGFR<br /><br>amplification </p><br>