Certain tumor bearings views using [18F]FMISO, INJ SOL in patiens with cancer disease.

• Conditions: Patients with sguamous cell carcinomas; MedDRA version: 14.1Level: PTClassification code 10041823Term: Squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000839-84-CZ
• Lead Sponsor: RadioMedic s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-22
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

•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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified