Fluorescence-guided Surgery Using CRGD-ZW800-1 in Oral Cancer (GuidedbyLight)

Erasmus University

Status and phase: Enrolling; Phase 2

Conditions: Squamous Cell Carcinoma of the Oral Cavity; Squamous Cell Carcinoma of the Head and Neck; Oral Cancer

Treatments: Drug: cRGD-ZW800-1.

Study type: Interventional

Funder types: Other

Identifiers

NCT04191460

2019-003416-30 (EudraCT Number)

12175

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 3 patient groups

WP-I dose A

Experimental group

Description:

n=7. Injection of 0.05 mg/kg cRGD-ZW800-1, within 16-20 hours before imaging/surgery

Treatment:

Drug: cRGD-ZW800-1.

WP-I dose B

Experimental group

Description:

n=7. Injection of (to be determined) mg/kg RGD-ZW800-1, within (to be determined) hours before imaging/surgery.

Treatment:

Drug: cRGD-ZW800-1.

WP-II selected dose

Experimental group

Description:

n=14: expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. Injection of 0.05 ór (to be determined) mg/kg cRGD-ZW800-1, within 48 hours before imaging/surgery.

Treatment:

Drug: cRGD-ZW800-1.