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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06158178
Other study ID # PETCT-Chol-Survival
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 8, 2017
Est. completion date November 23, 2017

Study information

Verified date December 2023
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

the increase in the serum PSA (prostate specific antigen) value following radical treatment commonly involves subsequent treatment which, in the absence of morphological evidence of disease recovery, is conducted empirically through local radiotherapy or systemic hormonal therapy. The use of PET with choline is therefore of extreme clinical interest as it allows to identify the site of disease recurrence, thus being able to direct towards a specific therapeutic treatment. The diagnostic accuracy of choline PET in identifying the location of the disease has been widely demonstrated in the literature and is comparable to those of conventional diagnostic methods previously described for the restaging of patients with prostatic disease. The real advantage of this method is the possibility of obtaining the same information as conventional methods by carrying out a single exam.


Recruitment information / eligibility

Status Completed
Enrollment 520
Est. completion date November 23, 2017
Est. primary completion date November 23, 2017
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult patients suffering from prostate cancer who have undergone choline PET/TC Exclusion Criteria: - patients < 18 years

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Diagnostic accuracy
The PET CT study with choline, being part of the normal standard diagnostic work-up of the patients, was performed following the normal clinical protocol. By analyzing the data retrospectively, the time elapsed following the prostatectomy operation and the follow up time after the choline PETCT study will be evaluated.

Locations

Country Name City State
Italy Irccs San Raffaele Milano Italia

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Choline PET-CT for the restaging of patients with prostatic disease. By analyzing the data retrospectively, the time elapsed following the prostatectomy operation and the follow up time after the choline PETCT study will be evaluated. 1 year
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