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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04191460
Recruitment Status : Not yet recruiting
First Posted : December 9, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Stijn Keereweer, Erasmus Medical Center

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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Oral Cancer Squamous Cell Carcinoma of the Oral Cavity Drug: cRGD-ZW800-1. Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024


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=15: expansion cohort (n=15) 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




Primary Outcome Measures :
  1. 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=15) will be added to the dose group that yields the highest TBR.

  2. WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins. [ Time Frame: through histopathology, up to max 4 weeks post-op ]

Secondary Outcome Measures :
  1. WP-II: Sensitivity, specificity, positive and negative predictive values [ Time Frame: through histopathology, up to max 4 weeks post-op ]
  2. WP-II: Co-localization of FLI with immunohistochemistry on pathology slides [ Time Frame: through histopathology, up to max 4 weeks post-op ]
  3. WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections [ Time Frame: through histopathology, up to max 4 weeks post-op ]
  4. WP-II: Operation time [ Time Frame: through histopathology, up to max 4 weeks post-op ]
  5. WP-II: FLI of lymph node metastases after neck dissection [ Time Frame: through histopathology, up to max 4 weeks post-op ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191460


Contacts
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Contact: Stijn Keereweer, MD PhD 010 704 13 57 s.keereweer@erasmusmc.nl

Locations
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Netherlands
Erasmus University Medical Center
Rotterdam, Zuid-Holland, Netherlands, 3015 GD
Contact: Stijn Keereweer, MD PhD         
Principal Investigator: Stijn Keereweer, MD PhD         
Sponsors and Collaborators
Erasmus Medical Center
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Responsible Party: Stijn Keereweer, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04191460    
Other Study ID Numbers: 12175
2019-003416-30 ( EudraCT Number )
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stijn Keereweer, Erasmus Medical Center:
cRGD-ZW800-1
fluorescence-guided surgery
image-guided surgery
fluorescence imaging
cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Mouth Neoplasms
Lip Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Lip Diseases