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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04191460
Other study ID # 12175
Secondary ID 2019-003416-30
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 12, 2022
Est. completion date March 1, 2025

Study information

Verified date February 2024
Source Erasmus Medical Center
Contact Stijn Keereweer, MD PhD
Phone 010 704 13 57
Email s.keereweer@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date March 1, 2025
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor; 2. = 18 years of age; 3. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations; 4. 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: 1. Previous surgery, chemotherapy or radiotherapy to the oral cavity; 2. History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent. 3. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential; 4. Patients with renal insufficiency (eGFR<60); 5. Patients with a previous kidney transplantation in the medical history; 6. 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; 7. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
cRGD-ZW800-1.
Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery

Locations

Country Name City State
Netherlands Erasmus University Medical Center Rotterdam Zuid-Holland

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary WP-I: (Highest) mean tumor-to-background ratio (TBR) Two dosages of cRGD-ZW800-1 are tested in two groups of each 7 patients. An expansion cohort (n=14) will be added to the dose group that yields the highest TBR. up to 48 ours post-dose
Primary WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins. through histopathology, up to max 4 weeks post-op
Secondary WP-II: Sensitivity, specificity, positive and negative predictive values through histopathology, up to max 4 weeks post-op
Secondary WP-II: Co-localization of FLI with immunohistochemistry on pathology slides through histopathology, up to max 4 weeks post-op
Secondary WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections through histopathology, up to max 4 weeks post-op
Secondary WP-II: Operation time through histopathology, up to max 4 weeks post-op
Secondary WP-II: FLI of lymph node metastases after neck dissection through histopathology, up to max 4 weeks post-op
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