Clinical trial · Interventional
Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer
Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
NCT04191460CI-TRIAL-00086487GuidedbyLightcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Oral Cavity | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cRGD-ZW800-1. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- WP-I dose A
- description
- n=7. Injection of 0.05 mg/kg cRGD-ZW800-1, within 16-20 hours before imaging/surgery
- interventionNames
- Drug: cRGD-ZW800-1.
- type
- EXPERIMENTAL
- label
- WP-I dose B
- description
- n=7. Injection of (to be determined) mg/kg RGD-ZW800-1, within (to be determined) hours before imaging/surgery.
- interventionNames
- Drug: cRGD-ZW800-1.
- type
- EXPERIMENTAL
- label
- WP-II selected dose
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.