NCT02443571

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
714

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

October 26, 2018

Completed
Last Updated

December 19, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

May 11, 2015

Results QC Date

May 26, 2017

Last Update Submit

November 27, 2018

Conditions

Prostatic Neoplasms

Keywords

observational study

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer

    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

    Up to 1 year post Fluciclovine 18F

Interventions

Fluciclovine (18F)RADIATION

Not applicable. This is an observational study.

Also known as: FACBC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University Hospital Sant'Orsola Malpighi

Bologna, 40138, Italy

Location

Oslo University Hospital

Oslo, 0424, Norway

Location

Aleris Kreftsenter

Oslo, N-0264, Norway

Location

Related 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 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.

    PMID: 27746282RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Blue Earth Diagnostics Ltd.
contact@blueearthdx.com
+44 (0) 1865 784 186

Study Officials

  • Penelope Ward, MBBS FFPM

    Blue Earth Diagnostics

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 14, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 19, 2018

Results First Posted

October 26, 2018

Record last verified: 2018-11

Locations

US(1)IT(1)NO(2)