Clinical trial NCT06835244: Diagnostic Performance of PET/CT-PSMA in Patients With Non-prostatic PSMA-expressing Neoplasms
Official title: Diagnostic Performance of PET/CT-PSMA in Patients With Non-prostatic PSMA-expressing Neoplasms: A Monocentric Observational Experience
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: PSMA Positive Tumors or Tumor Tissues
Cancer
Keywords: PSMA PET/CT
PSMA expressing tumors
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with neoplasms other than prostate carcinoma, referred to the Nuclear Medicine Unit to undergo a PET/CT scan with PSMA.

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: PSMA PET/CT performance
timeFrame: From the enrollment up to 10 years
Secondary outcomes:
measure: Prognostic and predictive value
timeFrame: From the enrollment up to 10 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Andrea Farolfi, MD
role: PRINCIPAL_INVESTIGATOR
References: