Retrospective Observational Study Investigating Fluciclovine (18F) (FACBC)

Blue Earth Diagnostics

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Radiation: Fluciclovine (18F)

Study type: Observational

Funder types: Industry

Identifiers

NCT02443571

Fluciclovine (18F) - BED - 001

Details and patient eligibility

About

This retrospective observational multi centered study has been established to collect the clinical experience relating to the administration of Fluciclovine 18F employed in both investigator initiated studies and named patient/compassionate use programmes in up to 5 sites.

Full description

This study will collect clinical data from consenting patients (unless a HIPAA waiver or equivalent was granted) who received the PET radiotracer Fluciclovine 18F (FACBC) (a synthetic amino acid analog) for imaging of patients with various cancers at participating sites in the US and Europe.

Data collection will cover baseline medical history and medications in all patients.

The result of PET radiotracer and other imaging findings, and reports of histopathology from biopsied tissue (where available) and in a time window relevant to the use of PET imaging in the diagnosis of primary/recurrent prostate cancer will be recorded.

In all subjects, with regards to safety monitoring, available data for physical examination, vital signs and laboratory test results will be collected from 28 days prior to and out to a 35 day window after Fluciclovine 18F (FACBC) administration.

The major goals of the investigation are to consolidate the safety profile of Fluciclovine 18F (FACBC), to evaluate its use in the detection of local and extraprostatic recurrence of prostate cancer and to evaluate its ability to detect malignancy in patients undergoing screening for primary prostate cancer.

Enrollment: 714 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient managed by a site at which ethical committee approval for retrospective data collection under this protocol has been received
• Patient has received at least one injection of fluciclovine (18F) for the detection of a malignant tumour at any location

Exclusion criteria

• Subjects will be excluded from the analyses if any of the following criteria are met:
• Patients participating in clinical trials or open access programmes at countries or sites not participating in this study.
• Patients managed at sites without ethical committee approval for retrospective data collection under this protocol.