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F18-Fluoride PET/CT for Bone Metastases
Phase 3
Waitlist Available
Led By Johannes Czernin, MD
Research Sponsored by American College of Radiology - Image Metrix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
The primary objective is to compare the diagnostic performance of 18F- Fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The intent of the study is to determine whether 18F-Fluoride PET/CT will lead to improved treatment and patient outcomes.
Eligible Conditions
- Bone Metastases
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning
Side effects data
From 2012 Phase 3 trial • 72 Patients • NCT016412372%
Mouth Ulceration
2%
Cough
2%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
NaF Dentifrice (1426 ppmF)
Placebo Dentifrice (0 ppmF)
NaF Dentifrice (250 ppmF)
NaF Dentifrice (1150 ppmF)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: F18-Fluoride PET/CTExperimental Treatment1 Intervention
Patients without known bone metastases who are newly diagnosed with ≥ stage 3 breast cancer, ≥ stage 3 lung cancer, or ≥ stage 2 prostate cancer (and/or PSA \>10 micrograms/L), including patient with recurrent breast, lung or prostate cancer; Patient is scheduled to undergo a conventional bone scan
Group II: TC-MDP Bone ScanActive Control1 Intervention
Patients without known bone metastases who are newly diagnosed with ≥ stage 3 breast cancer, ≥ stage 3 lung cancer, or ≥ stage 2 prostate cancer (and/or PSA \>10 micrograms/L), including patient with recurrent breast, lung or prostate cancer; Patient is scheduled to undergo a conventional bone scan
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Who is running the clinical trial?
American College of Radiology - Image MetrixLead Sponsor
2 Previous Clinical Trials
279 Total Patients Enrolled
World Molecular Imaging SocietyUNKNOWN
Johannes Czernin, MDPrincipal InvestigatorWorld Molecular Imaging Society
8 Previous Clinical Trials
1,484 Total Patients Enrolled
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