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=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 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
28
Start Date
October 1, 2021
Completion Date
December 1, 2023
Primary Completion Date
December 1, 2023
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;
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.
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
August 2021