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

Primary Purpose

Malignant Neoplasm of Prostate

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

[F-18] NaF PET/CT

[F-18] fluciclovine PET/CT

About this trial

This is an interventional diagnostic trial for Malignant Neoplasm of Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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) Definitely benign Probably benign Equivocal Probably malignant Definitely malignant

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)

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)

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)

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)

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04765423

First Posted

February 18, 2021

Last Updated

March 21, 2022

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04765423

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Poor patient accrual

Study Start Date

March 25, 2021 (Actual)

Primary Completion Date

March 18, 2022 (Actual)

Study Completion Date

March 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Neoplasm of Prostate

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

[F-18] NaF PET/CT

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

[F-18] fluciclovine PET/CT

Other Intervention Name(s)

Axumin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame