Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Not applicable. This is an observational study.

Fluciclovine (18F)

Penelope Ward, MBBS FFPM

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.

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.

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

A Retrospective Observational Study Investigating the Safety and Effectiveness of Fluciclovine (18F) (FACBC) PET Ligand in Human Subjects

Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events

Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.

Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan.

Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan.

Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan.

Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy.

Blue Earth Diagnostics

18F-Fluciclovine PET

Recurrent Prostate Cancer

Primary Prostate Cancer

Other Cancers

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Norway

Italy

Region of Enrollment

Chief Medical Officer

Treatment Emergent Adverse Events

Treatment Emergent Serious Adverse Events

Patients who have received at least one dose of Fluciclovine 18F

Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events

Subject PPV

Extraprostatic Region PPV

Prostate & Prostate Bed Region PPV

Standard of truth was histology. For the prostate/bed region standard TRUS/biopsy or MRI/TRUS fusion biopsy was used to establish truth while blinded to PET findings.

When feasible, clinically relevant 18F-fluciclovine positive extraprostatic areas underwent directed biopsy based on cognitive fusion of the PET/CT data with biopsy technique.

Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer

Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer

Detection Rate

Sensitivity

Specificity

Negative Predictive Value

Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer

Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer

Overall Study

Spots Global Cancer Trial Database for fluciclovine (18f)