Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy

September 17, 2019 updated by: Stanford University
Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool for cancer detection and monitoring response to therapy. Sodium Fluorine-18 (F-18) was used in the 1970s for bone scanning and can be used as a skeletal tracer in current PET/CT scanners. The combined administration of F-18 and F-18 FDG in a single PET/CT scan for cancer detection was not attempted to date. We hope to learn what is the best approach for detection of cancer and thus to improve cancer treatment.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

214

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

  • Denmark
      • Aalborg, Denmark
        • Aalborg Hospital
  • India
      • Chennai, India
        • Apollo Hospital
  • Portugal
      • Coimbra, Portugal
        • Coimbra University Hospital
  • South Africa
      • Pretoria, South Africa
        • Pretoria Academic Hospital
  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

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

All

Sampling Method

Non-Probability Sample

Study Population

Patients must be referred for evaluation of bone metastases.

Description

Inclusion Criteria:

  • Patients older than 18-year-old, diagnosed with cancer
  • Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them

Exclusion Criteria:

  • Patients who cannot complete a PET/CT scan
  • Pregnant women
  • Healthy volunteers
  • Patients participating in other research studies

The subjects will not be paid to participate in this protocol. No costs will be charged to the subjects.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of patients with evidence of new lesions on combined F-18/F-18 FDG PET/CT.
Time Frame: not defined
not defined

Collaborators and Investigators

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

Sponsor

Stanford University

Investigators

  • Principal Investigator: Andrei Iagaru M.D, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2007

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (ESTIMATE)

July 30, 2008

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAR0024
  • 98043 (OTHER: Stanford University Alternate IRB Approval No.)
  • SU-07232008-1266 (OTHER: Stanford University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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