Monocentric Observational Study on the Diagnostic and Prognostic Role of 18F-PSMA PET (PET/CT and PET/MR) in Prostate Cancer
1 other identifier
observational
2,500
1 country
1
Brief Summary
The general objective of this retrospective and prospective study is to evaluate the diagnostic and prognostic role of a quantitative analysis of PET images with 18F-PSMA in all stages of the disease in patients with prostate cancer. To this end, both imaging parameters commonly used in clinical practice and the contribution of radiomic features will be investigated. The latter are quantitative features extracted from biomedical images, and are believed to be able to provide information, otherwise impossible to investigate, useful for the characterization of various pathologies. This methodology is very promising, but also recent and therefore little studied and standardized. Our objective is also to investigate how to optimize it from a purely methodological point of view.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 13, 2022
CompletedFirst Submitted
Initial submission to the registry
November 24, 2023
CompletedFirst Posted
Study publicly available on registry
December 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 13, 2027
December 12, 2023
December 1, 2023
4.8 years
November 24, 2023
December 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
PET with 18F-PSMA for diagnostic accuracy for staging of prostate cancer.
the role of a quantitative-semi-quantitative analysis for the characterization of prostatic pathology in different phases of the disease.
5 years
Interventions
Subjects will be subjected to a PET examination according to international guidelines and where requested by the specialist. In particular, patients will be administered the radiopharmaceutical 18 F PSMA. Approximately two hours after administration, the patient is positioned on the PET/CT equipment table and image acquisition begins.
Eligibility Criteria
The study will enroll adult patients with a histopathological diagnosis of prostate cancer undergoing PET examination with 18 F-PSMA where requested by the specialist due to clinical need at the U.O. of nuclear medicine of the San Raffaele Hospital.
You may qualify if:
- adult male patients;
- patients with histopathological diagnosis of prostate cancer undergoing staging or restaging;
- patients with clinical indication for PET examination with 18 F-PSMA;
You may not qualify if:
- medical conditions that do not allow the acquisition of PET images;
- allergic reactions to iodinated contrast medium or creatinine levels \>2mg/dL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRC
Milan, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele
Study Record Dates
First Submitted
November 24, 2023
First Posted
December 12, 2023
Study Start
October 13, 2022
Primary Completion (Estimated)
July 13, 2027
Study Completion (Estimated)
July 13, 2027
Last Updated
December 12, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share