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

NCT04191460 | Recruiting Phase 2

• 2 other identifiers: 121752019-003416-30
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

cRGD-ZW800-1; fluorescence-guided surgery; image-guided surgery; fluorescence imaging; cancer

Outcome Measures

Primary Outcomes (2)

• 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

• WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins.

  through histopathology, up to max 4 weeks post-op

Secondary Outcomes (5)

• WP-II: Sensitivity, specificity, positive and negative predictive values

  through histopathology, up to max 4 weeks post-op

• WP-II: Co-localization of FLI with immunohistochemistry on pathology slides

  through histopathology, up to max 4 weeks post-op

• WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections

  through histopathology, up to max 4 weeks post-op

• WP-II: Operation time

  through histopathology, up to max 4 weeks post-op

• WP-II: FLI of lymph node metastases after neck dissection

  through histopathology, up to max 4 weeks post-op

Study Arms (3)

WP-I dose A

EXPERIMENTAL

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

Drug: cRGD-ZW800-1.

WP-I dose B

EXPERIMENTAL

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

Drug: cRGD-ZW800-1.

WP-II selected dose

EXPERIMENTAL

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.

Drug: cRGD-ZW800-1.

Interventions

cRGD-ZW800-1. DRUG

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

WP-I dose A; WP-I dose B; WP-II selected dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus University Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Related Links

• First in-human study of cRGD-ZW800-1 in patients with colorectal cancer

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Stijn Keereweer, MD PhD

CONTACT

010 704 13 57; s.keereweer@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: July 12, 2022
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)