NCT00725387

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
5 countries

5 active sites

Status
completed

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

Study Start

First participant enrolled

August 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

11.3 years

First QC Date

July 28, 2008

Last Update Submit

September 17, 2019

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Percent of patients with evidence of new lesions on combined F-18/F-18 FDG PET/CT.

    not defined

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients must be referred for evaluation of bone metastases.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Aalborg Hospital

Aalborg, Denmark

Location

Apollo Hospital

Chennai, India

Location

Coimbra University Hospital

Coimbra, Portugal

Location

Pretoria Academic Hospital

Pretoria, South Africa

Location

Related Publications (1)

  • Iagaru A, Mittra E, Mosci C, Dick DW, Sathekge M, Prakash V, Iyer V, Lapa P, Isidoro J, de Lima JM, Gambhir SS. Combined 18F-fluoride and 18F-FDG PET/CT scanning for evaluation of malignancy: results of an international multicenter trial. J Nucl Med. 2013 Feb;54(2):176-83. doi: 10.2967/jnumed.112.108803. Epub 2012 Dec 14.

    PMID: 23243299DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Andrei Iagaru M.D

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 30, 2008

Study Start

August 1, 2007

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

September 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)ZA(1)DK(1)IN(1)US(1)