Clinical trial NCT02443571: Retrospective Observational Study Investigating Fluciclovine (18F) (FACBC)
Official title: A Retrospective Observational Study Investigating the Safety and Effectiveness of Fluciclovine (18F) (FACBC) PET Ligand in Human Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Keywords: observational study
Lead sponsor: Blue Earth Diagnostics
Sponsor class: INDUSTRY
First posted: 2015-05-14
Enrollment: 714
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (male/female) who underwent PET scanning using fluciclovine (18F) as the radiotracer for the detection of cancer at a clinical site participating in this study.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
timeFrame: Up to 35 days post Fluciclovine 18F
measure: Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer
timeFrame: Up to 1 year post Fluciclovine 18F
measure: Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
timeFrame: Up to 1 year post Fluciclovine 18F
Secondary outcomes:
measure: Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer
timeFrame: Up to 1 year post Fluciclovine 18F
measure: Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
timeFrame: Up to 1 year post Fluciclovine 18F
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Bologna
country: Italy
facility: University Hospital Sant'Orsola Malpighi
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Oslo
country: Norway
facility: Aleris Kreftsenter
Study officials:
affiliation: Blue Earth Diagnostics
name: Penelope Ward, MBBS FFPM
role: STUDY_CHAIR
References:
citation: Bach-Gansmo T, Nanni C, Nieh PT, Zanoni L, Bogsrud TV, Sletten H, Korsan KA, Kieboom J, Tade FI, Odewole O, Chau A, Ward P, Goodman MM, Fanti S, Schuster DM, Willoch F. Multisite Experience of the Safety, Detection Rate and Diagnostic Performance of Fluciclovine (18F) Positron Emission Tomography/Computerized Tomography Imaging in the Staging of Biochemically Recurrent Prostate Cancer. J Urol. 2017 Mar;197(3 Pt 1):676-683. doi: 10.1016/j.juro.2016.09.117. Epub 2016 Oct 13.