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Trial Title:
Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial
NCT ID:
NCT05752149
Condition:
Squamous Cell Carcinoma of the Larynx
Squamous Cell Carcinoma of the Hypopharynx
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Hypopharyngeal Neoplasms
Conditions: Keywords:
Tumour specific fluorescence imaging
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Diagnostic
Masking:
Single (Care Provider)
Masking description:
The pathologist will be initially blinded during intraoperative assessment of the fresh
surgical specimen.
Intervention:
Intervention type:
Drug
Intervention name:
CRGD-ZW800-1
Description:
Intravenous administration of study drug at lesat 2h prior to surgery
Arm group label:
0.01 mg/kg cRGD-ZW800-1
Arm group label:
0.025 mg/kg cRGD-ZW800-1
Arm group label:
0.05 mg/kg cRGD-ZW800-1
Arm group label:
Expansion Cohort
Summary:
This is an open-label, single-dose, prospective clinical trial. The study comprises 2
work packages. The main objective of work package I (WP-1) is to assess feasibility of
Fluorescence imaing (FLI) during total laryngectomy (TLE) and to assess the optimal dose
of the cRGD-ZW800-1. Work package II (WP-II) is designed to assess whether FLI can detect
and decrease tumor positive margins after a TLE.
Detailed description:
This is a two staged clinical trial to investigate intraoperative fluorescence imaging in
patientsundergoing TLE. WP-I is a dose finding study in which 2 doses will be tested with
a possibility of a third dosing group. Every dosing cohort comprises 3 patients. After
WP-I, an interim analysis will be performed to decide the optimal dose.
The optimal dose will be based on the TBR and the performance in detecting the most close
margin (i.e. 'the sentinel margin'). A TBR of at least 1.5 is required for the optimal
dose. If a positive margin is missed with fluorescence imaging, the concerned dose will
be defined as suboptimal.
WP-II is an extension cohort of the optimal dose cohort selected in WP-I. WP-II will
comprise of 18 patients.
The endpoints for WP-II are:
- the rate of tumor free resection margins based on the current golden standard;
- Sensitivity, specificity and positive predictive value of FLI;
- The intraoperative change in surgical management based on FLI;
- FLI of excised cervical lymph nodes;
- Influence of previous radiotherapy on the FLI performance;
- Adverse events and toxicity after intravenous injection with cRGD-ZW800-1;
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with biopsy-proven squamous cell Laryngeal and hypopharyngeal cancer,
eligible for surgical resection of the tumor by TLE;
- ≥ 18 years of age;
- Written informed consent must be obtained;
- Sufficient knowledge of the Dutch language to understand the informed consent form;
Exclusion Criteria:
- History of a clinically significant allergy or anaphylactic reactions to any of the
components of the agent;
- Other synchronous biopsy proven malignancies currently active, except for adequately
treated in situ carcinoma of cervix and basal, squamous cell skin carcinoma, or
other head- and neck squamous cell cancer;
- Patients pregnant or breastfeeding;
- Patients with renal insufficiency (defined as eGFR < 60);
- Patients with previous kidney transplantation or a solitary functioning kidney;
- Patients using medications that may significantly impair renal function (i.e.
NSAIDs, particularly COX-2 inhibitors), that cannot be paused during the course of
the study;
- Patients with ASA classification of 4 or higher;
- Patients with measured QTc of 500 ms or higher at screening;
- Patients with laboratory abnormalities defined as:
- Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl
Transferase) or Alkaline Phosphatase 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).
- Immuno-compromised patients who do not have the ability to respond normally to an
infection due to an impaired or weakened immune system, caused by either a
preexisting disease or concomitant medications;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Erasmus Medical Center
Address:
City:
Rotterdam
Zip:
3015GD
Country:
Netherlands
Contact:
Last name:
Stijn Keereweer, MD, PhD
Start date:
September 2024
Completion date:
November 2025
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05752149
https://clinicaltrials.gov/ct2/show/NCT04191460?term=guided+by+light&draw=2&rank=1
