Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cRGD-ZW800-1..
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma of the Head and Neck, Oral Cancer, Squamous Cell Carcinoma of the Oral Cavity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
Overview
This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.
Detailed description
Work package I:
In WP-I, the preferred dose of the agent for imaging of margins in oral cancer will be determined. The signal-to-noise ratio will be determined in dose group A (n=7), which will receive 0.05 mg/kg of the tracer, 16-20 hours before surgery. After an interim evaluation of this ratio, the second dose group B (n=7) will receive either a higher or a lower dosage (to be determined) of the tracer. After inclusion of all patients (n=14), the dose with the highest intraoperative signal-to-noise ratio will be selected.
Work package II:
In WP-II, an expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. In this group of 21 patients, it will be determined if FLI can improve the rate of adequate surgical resection margins. As secondary research questions, the following aspects will be assessed:
* sensitivity, specificity, positive and negative predictive values of FLI; * colocalization with immunohistochemistry; * change in surgical management; incremental operation time; * FLI of excised cervical lymph nodes.
Interventions
- Drug cRGD-ZW800-1.
Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery
Primary outcome measures
- WP-I: (Highest) mean tumor-to-background ratio (TBR) [Time frame: up to 48 ours post-dose]
- WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins. [Time frame: through histopathology, up to max 4 weeks post-op]
Secondary outcome measures (5)
- WP-II: Sensitivity, specificity, positive and negative predictive values [Time frame: through histopathology, up to max 4 weeks post-op]
- WP-II: Co-localization of FLI with immunohistochemistry on pathology slides [Time frame: through histopathology, up to max 4 weeks post-op]
- WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections [Time frame: through histopathology, up to max 4 weeks post-op]
- WP-II: Operation time [Time frame: through histopathology, up to max 4 weeks post-op]
- WP-II: FLI of lymph node metastases after neck dissection [Time frame: through histopathology, up to max 4 weeks post-op]
Eligibility criteria
Inclusion criteria
- Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
- ≥ 18 years of age;
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations;
- Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.
Exclusion criteria
- Previous surgery, chemotherapy or radiotherapy to the oral cavity;
- History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
- Patients with renal insufficiency (eGFR<60);
- Patients with a previous kidney transplantation in the medical history;
- Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications;
- Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Netherlands · 1 center
- Erasmus University Medical Center — Rotterdam
Identifiers
NCT: NCT04191460 · 12175 · 2019-003416-30