Fluciclovine (Axumin) PET/CT vs. NaF PET/CT in Prostate Cancer Osseous Metastatic Disease

March 21, 2022 updated by: Case Comprehensive Cancer Center

[F-18] Fluciclovine (Axumin) PET/CT vs. [F-18] NaF PET/CT in the Evaluation of Prostate Cancer Osseous Metastatic Disease

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The study will assess the diagnostic performance of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT as the reference standard. Each bone lesion identified on [F-18] NaF PET/CT will be compared with the level of [F-18] fluciclovine uptake

The primary objective is to assess [F-18] fluciclovine efficacy in the evaluation of osseous metastatic disease in prostate cancer on a lesion-by-lesion comparison with [F-18] NaF as a the reference standard.

Study Type

Interventional

Phase

  • Not Applicable

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

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

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

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

-Cannot tolerate imaging up to 60 minutes of total imaging

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NaF PET/CT scan and F-18 fluciclovine PET/CT

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/CT
Radiotracer F-18 NaF used on the PET/CT imaging
Device: [F-18] fluciclovine PET/CT
F-18 fluciclovine (Axumin ®) used on the PET/CT camera
Other Names:
  • Axumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT
Time Frame: At time of scan, up to 60 minutes per scan

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
Time Frame: At time of scan, up to 60 minutes per scan

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
Time Frame: At time of scan, up to 60 minutes per scan

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)
Time Frame: At time of scan, up to 60 minutes per scan

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)
Time Frame: At time of scan, up to 60 minutes per scan

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)
Time Frame: At time of scan, up to 60 minutes per scan
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

Collaborators and Investigators

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

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Robert Jones, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

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 (ACTUAL)

March 25, 2021

Primary Completion (ACTUAL)

March 18, 2022

Study Completion (ACTUAL)

March 18, 2022

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (ACTUAL)

February 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE11820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plans to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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