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

NCT ID: NCT02443571

Last Updated: 2018-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

714 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Prostatic Neoplasms

Keywords

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observational study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Fluciclovine (18F)

Not applicable. This is an observational study.

Intervention Type RADIATION

Other Intervention Names

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FACBC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Blue Earth Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Penelope Ward, MBBS FFPM

Role: STUDY_CHAIR

Blue Earth Diagnostics

Locations

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Emory University Hospital

Atlanta, Georgia, United States

Site Status

University Hospital Sant'Orsola Malpighi

Bologna, , Italy

Site Status

Oslo University Hospital

Oslo, , Norway

Site Status

Aleris Kreftsenter

Oslo, , Norway

Site Status

Countries

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United States Italy Norway

References

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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.

Reference Type RESULT
PMID: 27746282 (View on PubMed)

Other Identifiers

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Fluciclovine (18F) - BED - 001

Identifier Type: -

Identifier Source: org_study_id