Patients with sguamous cell carcinomas MedDRA version: 14.1 Level: PT Classification code 10041823 Term: Squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [18F]FMISO, INJ SOL
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [18F]fluormisonidazol
CAS Number: 104613-87-8
Concentration unit: GBq gigabecquerel(s)
Concentration
Sponsors
RadioMedic s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •persons of both sexes of age 18 – 80 years •proven squamous cells carcinoma bearing, verified by PET scintigraphy using [18F]FDG, verified histologically •[18F]FDG PET examination performed for medical indication within 28 days before ivestgational preparation administration •signing the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: •suspicion of drug addiction •infectious or acute febrile illness within last 14 days before signing of informed consent •application of ionizing radiation from research reasons within last 10 years •chemotherapy finished in shorter term then 4 weeks or radiotherapy finished in shorter term then 3 months before application of testing preparation •suspicion of pregnancy (laboratory test of fertile age women with opportunity of pregnancy), nursing mother •significant renal disease (S-creatinine > 50% above upper normal limit, urea > 50% above upper normal limit) •significant signs of haemopoiesis (leukopenia < 1,5 x 10-9 / L, thrombocytopenia < 80 x 10-9 / L) •participation in another study •inability to co-operation •foreign nationality •person with limited legal capacity •dependent person (military service, punishment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Confirmation of accumulation of the IMP in the tumor.;Timepoint(s) of evaluation of this end point: Within 48 hours after the procedure in the time of reading images. ;Main Objective: The primary objective is to evaluate the PET scintigraphy results after application of ivestgational preparation [18F]FMISO, INJ SOL, and comparison with PET scintigraphy after [18F]FDG, which was performed on the same device using the same procedure within 28 days before the clinical trial. Objective evaluation of accumulation level in bounded area of interest (ROI) will be performed using SUVmax determination (ratio of activity per milliliter of tissue to applied activity, based on the patient weight after correction on physical decay of 18F). This value will be calculated by computer above evaluating tumor in the place of one or the other radiopharmaceutical accumulation. It is value, which is not affected by investigator and it is possible to consider it as an objective expression of accumulation level in selected area of iterest.;Secondary Objective: The secondary objective of the clinical trial is to confirm, that [18F]FMISO, INJ SOL application doesn´t cause adverse events including allergic symptoms or pyrogenicity expressions, furthermore that scintigraphic pictures of [18F]FMISO, INJ SOL accumulation correspond by the character to the pictures from nonclinical experiments on animals as well as to the pictures known from literature. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Side effects, change of physiological function, alergic reactions.;Timepoint(s) of evaluation of this end point: Acute changes within 2 hours after examination, chronic changes within 48 hours. | — |
Countries
Czech Republic
Contacts
Public ContactKlinické hodnocení
RadioMedic s.r.o.
Outcome results
None listed