NCT04765423

Brief Summary

The purpose of this study is to look at whether F-18 Fluciclovine (i.e. Axumin) is better or as good as F-18 Sodium Fluoride (F-18 NaF) when looking at bone disease from prostate cancer. Axumin is a radioactive agent used on a positron/computed tomography (PET/CT) camera to look for prostate cancer in general.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2022

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

February 18, 2021

Last Update Submit

March 21, 2022

Conditions

Malignant Neoplasm of Prostate

Outcome Measures

Primary Outcomes (6)

  • Number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT

    Agreement of imaging methods as measured by number of lesions seen by \[F-18\] NaF PET/CT which are also seen by \[F-18\] fluciclovine PET/CT broken down by diagnostic score on a lesion-by-lesion basis (1 to 5) 1. Definitely benign 2. Probably benign 3. Equivocal 4. Probably malignant 5. Definitely malignant

    At time of scan, up to 60 minutes per scan

  • Sensitivity

    Accuracy of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT evaluated via sensitivity Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN)

    At time of scan, up to 60 minutes per scan

  • Specificity

    Accuracy of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT evaluated via specificity Specificity is the number of true Negatives (TN) divided by the sum of TN and false positives (FP): Sensitivity = TN / (TN+FP)

    At time of scan, up to 60 minutes per scan

  • Positive Predictive Value (PPV)

    Accuracy of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT evaluated via PPV PPV is the number of true TP divided by the sum of TP and FP: Sensitivity = TP / (TP+FP)

    At time of scan, up to 60 minutes per scan

  • Negative Predictive Value (NPV)

    Accuracy of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT evaluated via NPV NPV is the number of true TN divided by the sum of TN and FN: Sensitivity = TN / (TN+FN)

    At time of scan, up to 60 minutes per scan

  • Area under the curve (AUC)

    Accuracy of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT evaluated via AUC using Receiver Operating Characteristic (ROC) curves

    At time of scan, up to 60 minutes per scan

Study Arms (1)

NaF PET/CT scan and F-18 fluciclovine PET/CT

EXPERIMENTAL

Visit 1: Participant receives a whole body \[F-18\] NaF PET/CT (diagnostic study) Visit 2: Participant receives a whole body \[F-18\] fluciclovine PET/CT within 3 weeks of Visit 1

Device: [F-18] NaF PET/CTDevice: [F-18] fluciclovine PET/CT

Interventions

[F-18] NaF PET/CTDEVICE

Radiotracer F-18 NaF used on the PET/CT imaging

NaF PET/CT scan and F-18 fluciclovine PET/CT
[F-18] fluciclovine PET/CTDEVICE

F-18 fluciclovine (Axumin ®) used on the PET/CT camera

Also known as: Axumin
NaF PET/CT scan and F-18 fluciclovine PET/CT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referred for initial staging or restaging of prostate cancers with clinical suspicion of bone metastases.
  • Must understand and voluntarily sign an Informed Consent Document

You may not qualify if:

  • Cannot tolerate imaging up to 60 minutes of total imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robert Jones, MD

    University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 21, 2021

Study Start

March 25, 2021

Primary Completion

March 18, 2022

Study Completion

March 18, 2022

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

No current plans to share IPD

Locations

US(1)