Please note that the ANZCTR website will be unavailable from 1pm until 2pm (AEST) on Wednesday 29th May for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00882609




Registration number
NCT00882609
Ethics application status
Date submitted
15/04/2009
Date registered
15/04/2009
Date last updated
28/11/2012

Titles & IDs
Public title
F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets
Scientific title
18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques
Secondary ID [1] 0 0
AMI-2008-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Metastases 0 0
Bone Metastases 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Bone Scan: F18-Fluoride PET/CT or TC-MDP
Treatment: Devices - Bone Scan: F18-Fluoride PET/CT or TC-MDP

Active Comparator: TC-MDP Bone Scan - 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

Experimental: F18-Fluoride PET/CT - 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

Active Comparator: TC-MDP Bone Scan - 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

Experimental: F18-Fluoride PET/CT - 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


Treatment: Devices: Bone Scan: F18-Fluoride PET/CT or TC-MDP
Each patient will be randomized into one of two groups with one group receiving Sodium Fluoride F18 Injection and the other receiving the control agent, 99mTc-MDPSodium Fluoride F18 Injection Dosing and Administration. The dose will be tailored for the specific patient for whom the dose was ordered. The dose of Sodium Fluoride F18 Injection administered will range from 5-10 mCi/patient.Each patient randomized to the control group will be administered 99mTc-MDP as a single intravenous bolus dose. The administered radioactivity will be determined based on the sites routine clinical practice for conventional bone imaging.

Treatment: Devices: Bone Scan: F18-Fluoride PET/CT or TC-MDP
Each patient will be randomized into one of two groups with one group receiving Sodium Fluoride F18 Injection and the other receiving the control agent, 99mTc-MDPSodium Fluoride F18 Injection Dosing and Administration. The dose will be tailored for the specific patient for whom the dose was ordered. The dose of Sodium Fluoride F18 Injection administered will range from 5-10 mCi/patient.Each patient randomized to the control group will be administered 99mTc-MDP as a single intravenous bolus dose. The administered radioactivity will be determined based on the sites routine clinical practice for conventional bone imaging.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning - The primary endpoint will be an analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The hypothesis is that PET/CT is superior to conventional bone scanning for detecting bone metastases. The primary metrics used for comparison will be the relative areas under the ROC curves generated by blinded core lab interpretations of the scans.
Timepoint [1] 0 0
6 Months
Primary outcome [2] 0 0
Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning - The primary endpoint will be an analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The hypothesis is that PET/CT is superior to conventional bone scanning for detecting bone metastases. The primary metrics used for comparison will be the relative areas under the ROC curves generated by blinded core lab interpretations of the scans.
Timepoint [2] 0 0
6 Months

Eligibility
Key inclusion criteria
- Patient is = 18 years old at the time of the drug administration (Patient may be male
or female of any race / ethnicity.)

- Patient or patient's legally acceptable representative cognitively provides written
informed consent

- 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

- Patient is capable of complying with study procedures

- Patient is able to remain still for duration of imaging procedure (about one hour)

- Patient may have had a prior PET or PET/CT scan for staging/restaging.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient is < 18 years old at the time of the drug administration

- Patient is pregnant or nursing;

- testing on site at the institution (urine or serum ßHCG) within 24 hours prior to
the start of investigational product administration

- obtaining surgical history (e.g., tubal ligation or hysterectomy)

- confirming the subject is post menopausal, with a minimum 1 year without menses

- Patient has any other condition or personal circumstance that, in the judgment of the
investigator, might interfere with the collection of complete good quality data

- Patient has known bone metastases

- Patient has previously received [18F]NaF in the last thirty days

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum - Melbourne
Recruitment postcode(s) [1] 0 0
8006 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Austria
State/province [10] 0 0
Linz
Country [11] 0 0
Portugal
State/province [11] 0 0
Coimbra
Country [12] 0 0
Switzerland
State/province [12] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
American College of Radiology - Image Metrix
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
World Molecular Imaging Society
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
World Molecular Imaging Society
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00882609
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johannes Czernin, MD
Address 0 0
World Molecular Imaging Society
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Johannes Czernin, MD
Address 0 0
Country 0 0
Phone 0 0
(310) 983-1443
Fax 0 0
Email 0 0
JCzernin@mednet.ucla.edu
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00882609