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

NCT06835244 | Enrolling By Invitation

• 1 other identifier: MORE - PSMA
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

PSMA Positive Tumors or Tumor Tissues; Cancer

Keywords

PSMA PET/CT; PSMA expressing tumors

Outcome Measures

Primary Outcomes (1)

• 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.

  From the enrollment up to 10 years

Secondary Outcomes (1)

• Prognostic and predictive value

  From the enrollment up to 10 years

Study Arms (1)

MORE PSMA POPULATION

Patients with tumors other than prostate cancer who may express PSMA

Other: 68Ga-PSMA-11

Interventions

68Ga-PSMA-11 OTHER

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

Also known as: PSMA PET/CT

MORE PSMA POPULATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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."

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Neoplasms

Interventions

gallium 68 PSMA-11

Study Officials

• Andrea Farolfi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 19, 2025
• Study Start: September 17, 2021
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: February 19, 2025

Record last verified: 2025-01

Locations

IT (1)