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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443571
• Other study ID #: Fluciclovine (18F) - BED - 001
• Status: Completed
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: November 2018
• Source: Blue Earth Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 714
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Radiation:
• Fluciclovine (18F)
Not applicable. This is an observational study.

Locations

Country	Name	City	State
Italy	University Hospital Sant'Orsola Malpighi	Bologna
Norway	Aleris Kreftsenter	Oslo
Norway	Oslo University Hospital	Oslo
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Blue Earth Diagnostics

Countries where clinical trial is conducted

United States,  Italy,  Norway, 

References & Publications (1)

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 Fluci — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events	Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events	Up to 35 days post Fluciclovine 18F
Primary	Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer	Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.	Up to 1 year post Fluciclovine 18F
Primary	Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer	Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.	Up to 1 year post Fluciclovine 18F
Secondary	Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer	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.	Up to 1 year post Fluciclovine 18F
Secondary	Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer	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.	Up to 1 year post Fluciclovine 18F