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

February 27, 2024 updated by: Stijn Keereweer, Erasmus Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Recruiting
        • Erasmus University Medical Center
        • Contact:
          • Stijn Keereweer, MD PhD
        • Principal Investigator:
          • Stijn Keereweer, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WP-I dose A
n=7. Injection of 0.05 mg/kg cRGD-ZW800-1, within 16-20 hours before imaging/surgery
Drug: cRGD-ZW800-1.
Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery
Experimental: WP-I dose B
n=7. Injection of (to be determined) mg/kg RGD-ZW800-1, within (to be determined) hours before imaging/surgery.
Drug: cRGD-ZW800-1.
Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery
Experimental: WP-II selected dose
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.
Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WP-I: (Highest) mean tumor-to-background ratio (TBR)
Time Frame: up to 48 ours post-dose
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.
Time Frame: through histopathology, up to max 4 weeks post-op
through histopathology, up to max 4 weeks post-op

Secondary Outcome Measures

Outcome Measure
Time Frame
WP-II: Sensitivity, specificity, positive and negative predictive values
Time Frame: through histopathology, up to max 4 weeks post-op
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
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
through histopathology, up to max 4 weeks post-op
WP-II: Operation time
Time Frame: through histopathology, up to max 4 weeks post-op
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
through histopathology, up to max 4 weeks post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12175
  • 2019-003416-30 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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