Back to resultsFluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer (GuidedbyLight)
Primary Purpose
Squamous Cell Carcinoma of the Head and Neck, Oral Cancer, Squamous Cell Carcinoma of the Oral Cavity
Status
Recruiting
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
cRGD-ZW800-1.
Sponsored by
About this trial
This is an interventional diagnostic trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring cRGD-ZW800-1, fluorescence-guided surgery, image-guided surgery, fluorescence imaging, cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Erasmus University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
WP-I dose A
WP-I dose B
WP-II selected dose
Arm Description
n=7. Injection of 0.05 mg/kg cRGD-ZW800-1, within 16-20 hours before imaging/surgery
n=7. Injection of (to be determined) mg/kg RGD-ZW800-1, within (to be determined) hours before imaging/surgery.
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.
Outcomes
Primary Outcome Measures
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.
WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins.
Secondary Outcome Measures
WP-II: Sensitivity, specificity, positive and negative predictive values
WP-II: Co-localization of FLI with immunohistochemistry on pathology slides
WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections
WP-II: Operation time
WP-II: FLI of lymph node metastases after neck dissection
Full Information
NCT ID
NCT04191460
First Posted
December 5, 2019
Last Updated
February 17, 2023
Sponsor
Erasmus Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04191460
Brief Title
Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer
Acronym
GuidedbyLight
Official Title
Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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=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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WP-I dose A
Arm Type
Experimental
Arm Description
n=7. Injection of 0.05 mg/kg cRGD-ZW800-1, within 16-20 hours before imaging/surgery
Arm Title
WP-I dose B
Arm Type
Experimental
Arm Description
n=7. Injection of (to be determined) mg/kg RGD-ZW800-1, within (to be determined) hours before imaging/surgery.
Arm Title
WP-II selected dose
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
cRGD-ZW800-1.
Intervention Description
Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery
Primary Outcome Measure Information:
Title
WP-I: (Highest) mean tumor-to-background ratio (TBR)
Description
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.
Time Frame
up to 48 ours post-dose
Title
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 Measure Information:
Title
WP-II: Sensitivity, specificity, positive and negative predictive values
Time Frame
through histopathology, up to max 4 weeks post-op
Title
WP-II: Co-localization of FLI with immunohistochemistry on pathology slides
Time Frame
through histopathology, up to max 4 weeks post-op
Title
WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections
Time Frame
through histopathology, up to max 4 weeks post-op
Title
WP-II: Operation time
Time Frame
through histopathology, up to max 4 weeks post-op
Title
WP-II: FLI of lymph node metastases after neck dissection
Time Frame
through histopathology, up to max 4 weeks post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stijn Keereweer, MD PhD
Phone
010 704 13 57
Email
s.keereweer@erasmusmc.nl
Facility Information:
Facility Name
Erasmus University Medical Center
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stijn Keereweer, MD PhD
First Name & Middle Initial & Last Name & Degree
Stijn Keereweer, MD PhD
12. IPD Sharing Statement
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/32345649/
Description
First in-human study of cRGD-ZW800-1 in patients with colorectal cancer
Learn more about this trial
Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer
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