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

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Tongue neoplasm
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Brief Title

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

Official Title

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

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.

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=15) will be added to the group of patients that had received
      the selected dose in WP-I. In this group of 22 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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

WP-I: (Highest) mean tumor-to-background ratio (TBR)

Secondary Outcome

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

Condition

Squamous Cell Carcinoma of the Head and Neck

Intervention

cRGD-ZW800-1.

Study Arms / Comparison Groups

 WP-I dose A
Description:  n=7. Injection of 0.05 mg/kg cRGD-ZW800-1, within 16-20 hours before imaging/surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

29

Start Date

January 2020

Completion Date

January 2024

Primary Completion Date

January 2024

Eligibility Criteria

        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.

        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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 010 704 13 57, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT04191460

Organization ID

12175

Secondary IDs

2019-003416-30

Responsible Party

Principal Investigator

Study Sponsor

Erasmus Medical Center

Study Sponsor

, ,

Verification Date

December 2019