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

November 27, 2018 updated by: Blue Earth Diagnostics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

714

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • University Hospital Sant'Orsola Malpighi
  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital
      • Oslo, Norway, N-0264
        • Aleris Kreftsenter
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Time Frame: Up to 35 days post Fluciclovine 18F
Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Up to 35 days post Fluciclovine 18F
Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer
Time Frame: Up to 1 year post Fluciclovine 18F
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
Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
Time Frame: Up to 1 year post Fluciclovine 18F
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer
Time Frame: Up to 1 year post Fluciclovine 18F

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
Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
Time Frame: Up to 1 year post Fluciclovine 18F

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blue Earth Diagnostics

Investigators

  • Study Chair: Penelope Ward, MBBS FFPM, Blue Earth Diagnostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fluciclovine (18F) - BED - 001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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