Diagnostic Performance of PET/CT-PSMA in Patients With Non-prostatic PSMA-expressing Neoplasms

N/AEnrolling By InvitationNCT06835244

IRCCS Azienda Ospedaliero-Universitaria di Bologna1,000 enrolled

Overview

Study to collect data from PET/CT-PSMA performed in patients with neoplasms expressing PSMA, other than prostate cancer. Objectives The primary objective is to evaluate the diagnostic performance of PET/CT-PSMA in the staging and management of patients with non-prostatic neoplasms expressing PSMA. The secondary objective is to analyze the prognostic value of PET-PSMA in such neoplasms and the possible use in the selection of patients eligible for target therapies against neovascularization (i.e. monoclonal anti-VEGF antibodies) and radiopharmaceutical treatments (i.e. 177Lu-PSMA).

Purpose of the register: This single-centre observational register is intended to collect data from PET/CT-PSMA performed in patients with neoplasms expressing PSMA, other than prostate cancer. Design of the register: observational, pharmacological, non-profit, prospective, monocentric. Duration of the record: The expected duration for the collection of PET/CT-PSMA examinations is 10 years. Objectives The primary objective of the following registry is to evaluate the diagnostic performance of PET/CT-PSMA in the staging and management of patients with non-prostatic neoplasms expressing PSMA. The secondary objective is to analyze the prognostic value of PET-PSMA in such neoplasms and the possible use in the selection of patients eligible for target therapies against neovascularization (i.e. monoclonal anti-VEGF antibodies) and radiopharmaceutical treatments (i.e. 177Lu-PSMA).

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

PSMA Positive Tumors or Tumor Tissues Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients diagnosed with a neoplasm other than prostate carcinoma who are referred to our unit as part of the standard care pathway to undergo a PSMA PET/CT scan for staging, restaging, and pre- and post-treatment evaluation * Signed informed consent for the collection and processing of data * Minimum age 18 years old." Exclusion Criteria: * pregnancy

Outcomes

Primary Outcomes

PSMA PET/CT performance

the evaluation of diagnostic performance of PSMA PET/CT and the positivity rate (%) globally and stratified by specific pathology in staging, re-staging and management of patients with non-prostatic neoplasms expressing PSMA.

Time frame: From the enrollment up to 10 years

Secondary Outcomes

Prognostic and predictive value

Prognostic and predictive values (%) of PSMA PET/CT in such cancers and the possible use in the selection of patients eligible for target therapies against neovascularization and radioligand treatment according to specific score of PSMA expressing cells (%).