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Enrolling by Invitation

NCT Number: NCT06835244

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

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).

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Key information

Conditions

PSMA Positive Tumors or Tumor Tissues Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68Ga-PSMA-11

Other

All patients with non prostatic neoplasm expressing PSMA undergo 68[Ga]Ga-PSMA-11-PET/CT

Other names: PSMA PET/CT

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 (%).

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: MORE-PSMA

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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