NCT00956163

Brief Summary

This phase 0 trial studies whole body fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) scan and whole body magnetic resonance imaging (MRI) in finding bone metastases in patients with prostate cancer. Diagnostic procedures, such as whole body fluorine F 18 sodium fluoride PET/CT scan and whole body MRI, may help find and diagnose bone metastases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2010

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 7, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 2, 2014

Status Verified

December 1, 2013

Enrollment Period

10 months

First QC Date

August 7, 2009

Last Update Submit

July 1, 2014

Conditions

Bone MetastasesRecurrent Prostate CancerStage I Prostate CancerStage IIA Prostate CancerStage IIB Prostate CancerStage III Prostate CancerStage IV Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Uptake of fluorine F 18 sodium fluoride on PET/CT scan

    Determine if increased uptake of 18F-fluoride on PET/CT scan is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard.

    Up to 24 months

  • Incidence of focal MRI abnormality

    Determine if focal MRI abnormality is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard.

    Up to 24 months

Study Arms (1)

Diagnostic (fluorine F 18 sodium fluoride PET)

EXPERIMENTAL

Patients undergo technetium Tc 99m methylene diphosphonate bone scan, fluorine F 18 sodium fluoride PET/CT scan, and whole-body MRI for the detection of bone metastases. Patients with discordant imaging results (negative bone scan and positive PET/CT scan and/or MRI) undergo additional imaging at 6, 12, 18, and 24 months.

Procedure: magnetic resonance imagingRadiation: fluorine F 18 sodium fluorideProcedure: positron emission tomographyProcedure: computed tomographyRadiation: technetium Tc 99m methylene diphosphonateOther: laboratory biomarker analysis

Interventions

magnetic resonance imagingPROCEDURE

Undergo whole-body MRI

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Diagnostic (fluorine F 18 sodium fluoride PET)
fluorine F 18 sodium fluorideRADIATION

Undergo fluorine F 18 sodium fluoride PET/CT scan

Also known as: 18 F-NaF, F-18 NaF
Diagnostic (fluorine F 18 sodium fluoride PET)
positron emission tomographyPROCEDURE

Undergo fluorine F 18 sodium fluoride PET/CT scan

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Diagnostic (fluorine F 18 sodium fluoride PET)
computed tomographyPROCEDURE

Undergo fluorine F 18 sodium fluoride PET/CT scan

Also known as: tomography, computed
Diagnostic (fluorine F 18 sodium fluoride PET)
technetium Tc 99m methylene diphosphonateRADIATION

Undergo technetium Tc 99m methylene diphosphonate bone scan

Also known as: 99mTc-MDP, TechneScan MDP, technetium Tc 99m medronate
Diagnostic (fluorine F 18 sodium fluoride PET)
laboratory biomarker analysisOTHER

Correlative studies

Diagnostic (fluorine F 18 sodium fluoride PET)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any ethnic group
  • Pathologically proven prostate cancer with high risk for bone metastases
  • Rising prostate-specific antigen (PSA) despite androgen deprivation therapy (ADT), PSA \> 10 ng/mL
  • Ability to understand and the willingness to sign a written combined Health Insurance Portability and Accountability Act (HIPAA) and informed consent document
  • Patients Eastern Cooperative Oncology Group (ECOG) performance is =\< 1

You may not qualify if:

  • Patients may not receive any other investigational therapeutic agents from within 7 days prior to study drug administration through 7 days following study drug administration
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients in this category are excluded to reduce medical risk to their safety and to avoid confounding variables in regard to the possibility of adverse events
  • Patient is unable to tolerate or has a lifer threatening allergy to the radiopharmaceutical used for bone scan or 18F-fluoride PET

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazoleTechnetium Tc 99m Medronate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesOrganotechnetium CompoundsOrganometallic CompoundsOrganic ChemicalsDiphosphonatesOrganophosphonatesOrganophosphorus Compounds

Study Officials

  • Mukesh Harisinghani

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2009

First Posted

August 11, 2009

Study Start

March 1, 2010

Primary Completion

January 1, 2011

Study Completion

May 1, 2014

Last Updated

July 2, 2014

Record last verified: 2013-12

Locations

US(1)