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Clinical Trials/EUCTR2014-005345-50-CZ
EUCTR2014-005345-50-CZ
Active, not recruiting
Phase 1

Diagnostic feasibility and morfological and functional correlation of PET examination in use of [18F]-Fluorocholin inj. in patients with prostate cancer - Fluoromethylcholinium-(18F)-chlorid inj.

Masarykuv onkologický ústav0 sitesMarch 3, 2015
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Masarykuv onkologický ústav
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 3, 2015
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
Masarykuv onkologický ústav

Eligibility Criteria

Inclusion Criteria

  • •age \= 18 years
  • •clinically localized/locally progressed prostate cancer\- high risk group (clinical stage cT2c or higher or PSA higher than 20 ng/ml or Gleason score more than 8\-10\) before the planned curative therapy to exclude a metastatic impairment
  • •examination of the disseminated prostate cancer to assess the impaired area
  • •biochemical recidive after a radical treatment od prostate cancer to localise the recidive and eventually to plan a targeted local therapy
  • •signed informed consent
  • •ECOG PS 0\-1
  • •Laboratory values:
  • •bilirubin \< 1,5x maximum normal value
  • •creatinine \< 1,5x maximum normal value
  • •urea \< 1,5x maximum normal value

Exclusion Criteria

  • •hypersensitivity to any compound of the investigational medicinal product
  • •renal impairment
  • •urea \> 1,5x maximum normal value
  • •creatinine \> 1,5x maximum normal value
  • •presence of any psychical, familial, social or geographic obstacles which could cause noncompliance with the protocol. These facts must be discussed with the subject prior to his/her inclusion
  • •weight more than 204 kg or deformity of thorax that could make the passage of the gantry of the device (diameter 70 cm) impossible
  • •claustrophobia or incapacity to lie 20 minutes without moving

Outcomes

Primary Outcomes

Not specified

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