Phase 2
N=114
Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00375830 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy — 10; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bone scan (Procedure); 99mTc-methyl diphosphonate (Drug); Positron Emission Tomography (PET) scan (Procedure); 18F-Fludeoxyglucose (18F-FDG) (Drug); Computed Tomography (CT) scan (Procedure); 18F-Sodium Fluoride (18F-NaF) (Drug); Whole Body Magnetic Resonance Imaging (WB-MRI) scan (Procedure); Gadopentetate dimeglumine (Drug); Gadofosveset (Drug); Gadobutrol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy |
10; 0; 0 | — |
| SECONDARY Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT |
3; 0; 0 | — |
| SECONDARY Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT |
5; 2; 1 | — |
| SECONDARY Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT |
0; 6; 3 | — |
| SECONDARY Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT |
9; 6; 0; 3 | — |
| SECONDARY Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions |
92.9; 92.9; 81.3; 86.7; 76.5; 82.4 | — |
| SECONDARY Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions |
96.2; 81.4; 89.8; 74.7 | — |
| SECONDARY Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions |
96.2; 64.6; 89.8; 65.9 | — |
| SECONDARY Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI |
95.7; 83.3; 87.6; 76.0 | — |
| SECONDARY Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy |
95.7; 91.6; 87.6; 83.0 | — |
| SECONDARY Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI |
37; 45 | — |
| SECONDARY Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI |
81; 140 | — |
Summary
This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer.
Eligibility Criteria
All patients were enrolled after receiving a regular medical care bone scan using the radiolabel 99mTc-methyl diphosphonate (t99-MDP).
INCLUSION CRITERIA
- ≥ 18 years old at the time of the drug administration
- ≥ Stage 3 breast cancer OR ≥ stage 2 prostate cancer OR prostate-specific antigen (PSA) > 10 micrograms/L OR recurrent breast or prostate cancer
- Capable of complying with study procedures
- Able to remain still for duration of imaging procedure (about one hour)
- Written informed consent
EXCLUSION CRITERIA
- Pregnant or nursing
- Metallic implants that contraindicate MRI
- Renal function impairment that contraindicates MRI
Data sourced from ClinicalTrials.gov (NCT00375830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.