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Trial record 63 of 292 for:    Sodium Fluoride OR Duraphat

F-18 Sodium Fluoride in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01240551
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : December 24, 2014
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Karen Kurdziel, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prostate Neoplasm
Intervention Drug: F-18 NaF
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mets Via NaF-18 PET/CT No-Mets Via NaF-18 PET/CT
Hide Arm/Group Description F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period. F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
Period Title: Overall Study
Started 30 30
Completed 26 27
Not Completed 4 3
Reason Not Completed
Refused further treatment             3             2
Lost to Follow-up             1             1
Arm/Group Title Mets Via NaF-18 PET/CT No-Mets Via NaF-18 PET/CT Total
Hide Arm/Group Description F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period. F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  50.0%
14
  46.7%
29
  48.3%
>=65 years
15
  50.0%
16
  53.3%
31
  51.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
64.1  (7.45) 65.8  (8.67) 64.98  (8.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
30
 100.0%
30
 100.0%
60
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Hispanic or Latino
1
   3.3%
0
   0.0%
1
   1.7%
Not Hispanic or Latino
29
  96.7%
30
 100.0%
59
  98.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  26.7%
6
  20.0%
14
  23.3%
White
22
  73.3%
24
  80.0%
46
  76.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30
 100.0%
30
 100.0%
60
 100.0%
1.Primary Outcome
Title Number of Participants With Present or Not Present Bone Metastasis
Hide Description Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake.
Time Frame Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.
Hide Outcome Measure Data
Hide Analysis Population Description
Patient with known prostate cancer. One group with known metastatic bone disease, based on prior clinical imaging scan (Tc-99m bone scan or NaF-18 bone scan or CT, and a second group with clinical risk factors for obtaining bony metastatic disease (i.e. pelvic soft tissue mets, high PSA (prostate specific antigen) blood levels).
Arm/Group Title Mets Via NaF-18 PET/CT No-Mets Via NaF-18 PET/CT
Hide Arm/Group Description:
F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
Overall Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline: Metastasis Present
30
 100.0%
10
  33.3%
Baseline: Metastasis Not Present
0
   0.0%
20
  66.7%
4-6 months: Metastasis Present
29
  96.7%
9
  30.0%
4-6 months: Metastasis not Present
0
   0.0%
20
  66.7%
10-12 months: Metastasis Present
26
  86.7%
7
  23.3%
10-12 months: Metastasis Not Present
7
  23.3%
13
  43.3%
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.
Time Frame date treatment consent signed to date off study, approximately 52.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mets Via NaF-18 PET/CT No-Mets Via NaF-18 PET/CT
Hide Arm/Group Description:
F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
Overall Number of Participants Analyzed 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.3%
1
   3.3%
Time Frame Date treatment consent signed to date off study, approximately 52.5 months.
Adverse Event Reporting Description Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.
 
Arm/Group Title Mets Via NaF-18 PET/CT No-Mets Via NaF-18 PET/CT
Hide Arm/Group Description F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period. F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
All-Cause Mortality
Mets Via NaF-18 PET/CT No-Mets Via NaF-18 PET/CT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Mets Via NaF-18 PET/CT No-Mets Via NaF-18 PET/CT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      0/30 (0.00%)    
Cardiac disorders     
Atrial fibrillation  1  1/30 (3.33%)  1 0/30 (0.00%) 
Nervous system disorders     
Syncope  1  1/30 (3.33%)  1 0/30 (0.00%) 
Renal and urinary disorders     
Renal calculi  1  1/30 (3.33%)  1 0/30 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mets Via NaF-18 PET/CT No-Mets Via NaF-18 PET/CT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      1/30 (3.33%)    
General disorders     
Pain  1  0/30 (0.00%)  1/30 (3.33%)  1
Renal and urinary disorders     
Hematuria  1  1/30 (3.33%)  1 0/30 (0.00%) 
Urinary incontinence  1  1/30 (3.33%)  1 0/30 (0.00%) 
Urinary tract pain  1  1/30 (3.33%)  1 0/30 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Karen Kurdziel
Organization: National Cancer Institute
Phone: 301-443-0622
EMail: kurdziek@mail.nih.gov
Layout table for additonal information
Responsible Party: Karen Kurdziel, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01240551     History of Changes
Other Study ID Numbers: 110021
11-C-0021
First Submitted: November 11, 2010
First Posted: November 15, 2010
Results First Submitted: December 15, 2014
Results First Posted: December 24, 2014
Last Update Posted: November 6, 2017