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

February 13, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Diagnostic Performance of PET/CT-PSMA in Patients With Non-prostatic PSMA-expressing Neoplasms: A Monocentric Observational Experience

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MORE PSMA POPULATION
Patients with tumors other than prostate cancer who may express PSMA
Other: 68Ga-PSMA-11
All patients with non prostatic neoplasm expressing PSMA undergo 68[Ga]Ga-PSMA-11-PET/CT
Other Names:
  • PSMA PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSMA PET/CT performance
Time Frame: From the enrollment up to 10 years
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.
From the enrollment up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic and predictive value
Time Frame: From the enrollment up to 10 years
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 (%).
From the enrollment up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Andrea Farolfi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2021

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MORE - PSMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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