EUCTR2009-014839-21-FR
Active, not recruiting
Phase 1
Diagnostic value of 18F-choline PET/CT for the detection of systemic prostate cancer disease. - 2008-CaP-FCH
CIS bio international, member of IBA group0 sites150 target enrollmentSeptember 7, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- de novo patients with histologically confirmed prostate cancer
- Sponsor
- CIS bio international, member of IBA group
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •2\. Age \> or \= 18 years
- •3\. De novo patient with histologically confirmed prostate cancer and high risk disease according to D’AMICO criteria: stages \> or \= T2c and/or PSA \> or \= 20 ng/ml and/or Gleason score \> or \= 8, or Gleason score \= 7 with either predominance of grade 4 or percentage of positive biopsy \> 50%
- •4\. Patient who has already been imaged by contrast\-enhanced thoraco\-abdominal CT and bone scintigraphy
- •5\. Patient who is able to undergo all study procedures and who has signed a written informed consent form to participate in the study
- •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
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Surgery within the last 4 weeks prior to the administration of \[18F]\-FCH
- •2\. History of other malignant tumor
- •3\. Previous radiation therapy
- •4\. Prostate biopsy within 4 weeks before \[18F]\-FCH PET/CT
- •5\. Concomitant medications containing choline
- •6\. Severe allergic reaction to any of the ingredients of the choline formulation
- •7\. Participation in another clinical study within one month prior to inclusion
- •8\. Uncooperative, in the investigator's opinion
- •9\. Linguistic or psychological inability to sign the informed consent form and/or take part in the study
- •10\. Having already participated in this clinical trial
Outcomes
Primary Outcomes
Not specified
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