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

NCT ID: NCT04765423

Last Updated: 2022-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2022-03-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malignant Neoplasm of Prostate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

[F-18] NaF PET/CT

Intervention Type DEVICE

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

[F-18] fluciclovine PET/CT

Intervention Type DEVICE

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

Interventions

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[F-18] NaF PET/CT

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

Intervention Type DEVICE

[F-18] fluciclovine PET/CT

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

Intervention Type DEVICE

Other Intervention Names

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Axumin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Jones, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Locations

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University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CASE11820

Identifier Type: -

Identifier Source: org_study_id

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