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

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ClinicalTrials.gov Identifier: NCT02443571
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : October 26, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Blue Earth Diagnostics

Study Description
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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.

Condition or disease Intervention/treatment
Prostatic Neoplasms Radiation: Fluciclovine (18F)

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 Design
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Study Type : Observational
Actual Enrollment : 714 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Observational Study Investigating the Safety and Effectiveness of Fluciclovine (18F) (FACBC) PET Ligand in Human Subjects
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Intervention Details:
  • Radiation: Fluciclovine (18F)
    Not applicable. This is an observational study.
    Other Name: FACBC

Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443571


Locations
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United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Italy
University Hospital Sant'Orsola Malpighi
Bologna, Italy, 40138
Norway
Oslo University Hospital
Oslo, Norway, 0424
Aleris Kreftsenter
Oslo, Norway, N-0264
Sponsors and Collaborators
Blue Earth Diagnostics
Investigators
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Study Chair: Penelope Ward, MBBS FFPM Blue Earth Diagnostics
More Information
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Publications of Results:

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Responsible Party: Blue Earth Diagnostics
ClinicalTrials.gov Identifier: NCT02443571    
Other Study ID Numbers: Fluciclovine (18F) - BED - 001
First Posted: May 14, 2015    Key Record Dates
Results First Posted: October 26, 2018
Last Update Posted: December 19, 2018
Last Verified: November 2018
Keywords provided by Blue Earth Diagnostics:
observational study
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases