primary ovarian carcinoma and primary non small cell lung carcinoma
Conditions
Interventions
Product Code: EC17
Pharmaceutical Form: Solution for injection
INN or Proposed INN: n.a.
CAS Number: n.a.
Current Sponsor code: EC17
Other descriptive name: Folate-5-fluorescein isothiocyanate
Concent
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General Inclusion Criteria 1. Subjects 18 years of age and older 2. Normal and clinically acceptable medical history, medical physical examination and vital signs at screening 3. Patients are clinically fit for surgery 4. Absence of anaphylactic reactions to EC17 or insects or allergy to fluorescein 5. No pregnancy, excluded by pregnancy test 6. The patients screening ECG and clinical laboratory test results are within normal range or are clinically insignificant 7. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 8. Before patient registration, written informed consent must be given 9. No impaired renal or liver function. Impaired renal function defined as eGFR=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of a single dose of intravenous EC17 injection in patients with ovarian or lung cancer. To assess concordance of fluorescent signal and tumor status of resected tissue. ;Secondary Objective: To assess the efficacy of EC17 for the intra-operative detection of FR-a positive ovarian or lung cancer. Feasibility to detect tumor positive resection margins with intra-operative fluorescence imaging. ;Primary end point(s): 1. Concordance rate of at least 80% between the pathology results and the imaging assessment 2. Safety: TEAE’ using MedDRA for the administration of EC17 during the study period (cycle of 14 days), and relevant changes in serum biochemistry, vital signs, injection site status and general physical examination. ;Timepoint(s) of evaluation of this end point: Endpoint 1: From administration up to 14 days post dose Endpoint 2: From predose to infinity | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. TBR signal, defined as fluorescent signal of tumor tissue compared to fluorescence signal of tissue surrounding the tumor. 2. Number and location of FR-a+, cancer+ tumor lesions identified under normal light only, under both normal light and fluorescent light, and under fluorescent light only. 3. Pharmacokinetics: Cmax, T½, AUC, Tmax, Clearance;Timepoint(s) of evaluation of this end point: Endpoint 1 & 2: From start to end of surgical procedure Endpoint 3: From predose up to 24 hours post dose | — |
Countries
Netherlands
Contacts
Public ContactRecruitment
Centre for Human Drug Research
Outcome results
None listed