Trial Outcomes & Findings for Fluorine F 18 Sodium Fluoride PET/CT and Whole Body and Axial MRI in Finding Metastases in Patients With Recurrent Prostate Cancer (NCT NCT01967862)
NCT ID: NCT01967862
Last Updated: 2020-09-17
Results Overview
Count of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2020-09-17
Participant Flow
Participant milestones
| Measure |
Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT)
Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.
computed tomography: Undergo CT
bone scan: Undergo bone scan
3-Tesla magnetic resonance imaging: Undergo axial MRI
diffusion-weighted magnetic resonance imaging: Undergo WB MRI
fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT
computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT
positron emission tomography: Undergo fluorine F 18 sodium fluoride PET/CT
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fluorine F 18 Sodium Fluoride PET/CT and Whole Body and Axial MRI in Finding Metastases in Patients With Recurrent Prostate Cancer
Baseline characteristics by cohort
| Measure |
Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT)
n=54 Participants
Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.
computed tomography: Undergo CT
bone scan: Undergo bone scan
3-Tesla magnetic resonance imaging: Undergo axial MRI
diffusion-weighted magnetic resonance imaging: Undergo WB MRI
fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT
computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT
positron emission tomography: Undergo fluorine F 18 sodium fluoride PET/CT
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsCount of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease.
Outcome measures
| Measure |
Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT)
n=54 Participants
Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.
computed tomography: Undergo CT
bone scan: Undergo bone scan
3-Tesla magnetic resonance imaging: Undergo axial MRI
diffusion-weighted magnetic resonance imaging: Undergo WB MRI
fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT
computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT
positron emission tomography: Undergo fluorine F 18 sodium fluoride PET/CT
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan.
Positive CT Scan
|
0 Participants
|
|
Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan.
Positive Bone Scan
|
0 Participants
|
|
Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan.
Positive MRI
|
12 Participants
|
|
Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan.
Positive PET
|
17 Participants
|
Adverse Events
Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT)
n=54 participants at risk
Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.
computed tomography: Undergo CT
bone scan: Undergo bone scan
3-Tesla magnetic resonance imaging: Undergo axial MRI
diffusion-weighted magnetic resonance imaging: Undergo WB MRI
fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT
computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT
positron emission tomography: Undergo fluorine F 18 sodium fluoride PET/CT
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/54 • Number of events 1 • Adverse Event occurred over a period of 1 year and 10 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/54 • Number of events 1 • Adverse Event occurred over a period of 1 year and 10 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic lesion
|
1.9%
1/54 • Number of events 1 • Adverse Event occurred over a period of 1 year and 10 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hot flashes
|
1.9%
1/54 • Number of events 1 • Adverse Event occurred over a period of 1 year and 10 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place