Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors

NCT ID: NCT03453528

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-04
• Study Completion Date: 2025-01-03

Brief Summary

multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.

Detailed Description

Multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.

The primary objective of this study is to evaluate the detection rate of PSMA PET/CT, defined as the ratio of PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one PSMA-positive lesion.

Conditions

Prostate-specific Membrane Antigen; mCRPC or Advanced/Metastatic Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-PSMA

68Ga-PSMA

Group Type: EXPERIMENTAL

68Ga-PSMA

Intervention Type: DRUG

68Ga-PSMA will be injected intravenously via an indwelling catheter in an antecubital vein; (68Ga-PSMA activity: min 100 MBq - max 200 MBq, weighted activity: 2.0 MBq/Kg).

Interventions

68Ga-PSMA

68Ga-PSMA will be injected intravenously via an indwelling catheter in an antecubital vein; (68Ga-PSMA activity: min 100 MBq - max 200 MBq, weighted activity: 2.0 MBq/Kg).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with mCRPC or advanced/metastatic solid tumors;

2. Male or Female, aged >18 years;

3. Written informed consent;

4. Relapse or progression of disease on CT scan and / or MRI;

5. If female of childbearing potential, highly effective birth control methods according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials" (2014_09_15 section 4.1) are mandatory, beginning at the screening visit and continuing until 6 months following last 68Ga-PSMA PET/CT.

6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria

1. Pregnancy / Nursing;

2. Participation in another clinical trial with any investigational agents within 30 days prior to study entry

3. Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent.

4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study.

5. inability to remain still for the entire duration of the exam

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paola Caroli, MD

Role: STUDY_CHAIR

IRST IRCCS

Locations

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, FC, Italy

Countries

Italy

Other Identifiers

IRST100.34

Identifier Type: -

Identifier Source: org_study_id