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Clinical Trials/EUCTR2011-000839-84-CZ
EUCTR2011-000839-84-CZ
Active, not recruiting
Not Applicable

Clinical assessment of the tissue distribution of [18F]FMISO, INJ SOL after intravenous injection in patiens with malignancy

RadioMedic s.r.o.0 sitesOctober 22, 2012
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ConditionsPatients with sguamous cell carcinomasMedDRA 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]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients with sguamous cell carcinomas
Sponsor
RadioMedic s.r.o.
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 22, 2012
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
RadioMedic s.r.o.

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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