Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer

Официальное название

Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат cRGD-ZW800-1.
  Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery

Первичные конечные точки

• WP-I: (Highest) mean tumor-to-background ratio (TBR) [Срок оценки: up to 48 ours post-dose]
• WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins. [Срок оценки: through histopathology, up to max 4 weeks post-op]

Вторичные конечные точки (5)

• WP-II: Sensitivity, specificity, positive and negative predictive values [Срок оценки: through histopathology, up to max 4 weeks post-op]
• WP-II: Co-localization of FLI with immunohistochemistry on pathology slides [Срок оценки: through histopathology, up to max 4 weeks post-op]
• WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections [Срок оценки: through histopathology, up to max 4 weeks post-op]
• WP-II: Operation time [Срок оценки: through histopathology, up to max 4 weeks post-op]
• WP-II: FLI of lymph node metastases after neck dissection [Срок оценки: through histopathology, up to max 4 weeks post-op]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Нидерланды · 1 центр

• Erasmus University Medical Center — Rotterdam

Идентификаторы

NCT: NCT04191460 · 12175 · 2019-003416-30

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗