CRGD-ZW800-1 for Squamous cell carcinoma of the larynx and hypopharynx

Inclusion criteria

• {"criterion_text":"- Patients with biopsy-proven squamous cell LHC, eligible for surgical resection of the tumor by TL(P)"}
• {"criterion_text":"- ≥ 18 years of age"}
• {"criterion_text":"- Written informed consent must be obtained"}
• {"criterion_text":"- Sufficient knowledge of the Dutch language to understand the informed consent form"}

Exclusion criteria

• {"criterion_text":"- History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent"}
• {"criterion_text":"- Patients with laboratory abnormalities defined as: Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or AlkalinePhosphatase levels above 5 times the ULN or; Total bilirubin above 3 times the ULN or; Platelet count below 100 x 109/L or; Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males)"}
• {"criterion_text":"- Incapacitated subjects"}
• {"criterion_text":"- Other synchronous biopsy proven malignancies currently active, except for adequately treated in situ carcinoma of cervix and basal or squamous cell skin carcinoma"}
• {"criterion_text":"- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential"}
• {"criterion_text":"- Patients with renal insufficiency (defined as eGFR<60)"}
• {"criterion_text":"- Patients with previous kidney transplantation or a solitary functioning kidney"}
• {"criterion_text":"- Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impairedor weakened immune system, caused by either a pre-existing disease or concomitant medications"}
• {"criterion_text":"- Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX- 2inhibitors), that cannot be paused during the course of the study"}
• {"criterion_text":"- Patients with ASA classification of 4 or higher"}
• {"criterion_text":"- Patients with measured QTc of 500 ms or higher at screening"}

Primary endpoints

• {"endpoint_text":"- The primary study endpoint of WP-1 is the tumor-to-background ratio (TBR) of laryngeal or pharyngeal tumours with fluorescence imaging after cRGD-ZW800-1 administration.","definition_or_measurement_approach":"Tumor-to-Background ratio (TBR); feasibility defined as TBR >1.5"}
• {"endpoint_text":"- The primary endpoint of WP-II is the number of clear resection margins","definition_or_measurement_approach":"Number of clear resection margins assessed post-surgery (as stated; no additional measurement detail provided)"}

Netherlands

Earliest CTIS Part Ii Submission Date

02-12-2024

Latest Decision Or Authorization Date

17-04-2025

Processing Time Days

136

Number Of Sites

1

Number Of Participants

27

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands