Trial Review

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 registered on ANZCTR


Registration number
ACTRN12609000120279
Ethics application status
Approved
Date submitted
29/12/2008
Date registered
19/02/2009
Date last updated
19/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Detection of Bony Metastases: Preliminary Study of 18F-Fluoride Positron Emission Tomography/Computed Tomography (PET/CT)
Scientific title
Is 18F-Fluoride Positron Emission Tomography/Computed Tomography (PET/CT) a beneficial test in detecting bony metastases in cancer patients with high risk of metastasis or suspicious/equivocal findings for bony metastasis by conventional studies?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Detection of bony metastasis 4161 0
Condition category
Condition code
Cancer 4370 4370 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
18F-Fluoride PET/CT is a noninvasive diagnostic imaging examination which involves intravenous injection of an isotope tracer (with a dosage of 7.0 mCi +/- 10%) followed by a whole-body scan of approximate 20 minutes (with the patient in the supine position). The participant will receive this examination one time which will take a total duration of less than 2 hours.
Intervention code [1] 3877 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5244 0
The presence or absence of bony metastasis as assessed by histological proof and/or clinical follow-up by the attending professional oncologist at out-patient clinic every 3 months with the aid of related imaging examinations such as X-ray, computed tomography (CT), magnetic resonance imaging (MRI), and traditional bone scan (which is different from the 18F-Fluoride Positron Emission Tomography/Computed Tomography as described in the intervention field) at the attending professional oncologist's discretion
Timepoint [1] 5244 0
This outcome will be assessed every 3 months post-intervention until 1 year for each participant (this outcome is not measured at baseline)
Secondary outcome [1] 8842 0
Overall survival as assessed by questionnaires
Timepoint [1] 8842 0
On a yearly basis until death
Secondary outcome [2] 9111 0
Clinical impact (treatment change due to 18F-Fluoride PET/CT) as assessed by surveys for the professional oncologists for all participants
Timepoint [2] 9111 0
after one year of follow-up for each participant

Eligibility
Key inclusion criteria
1. patients with histological diagnosis of breast cancer, head and neck cancer, lung cancer, gynecological cancer, genitourinary cancer, or colorectal cancer
2. high risk of or suspicious/equivocal findings for bony metastasis by conventional studies
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with more than one type of cancer
2. patients with pregnancy or breast-feeding

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 1502 0
Taiwan, Province Of China
State/province [1] 1502 0

Funding & Sponsors
Funding source category [1] 4332 0
Government body
Name [1] 4332 0
National Science Council, Taiwan
Country [1] 4332 0
Taiwan, Province Of China
Primary sponsor type
Government body
Name
National Science Council, Taiwan
Address
No.106, Sec. 2, Heping E. Rd., Da-an District, Taipei City 106, Taiwan (R.O.C.)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 3902 0
Hospital
Name [1] 3902 0
Chang Gung Memorial Hospital
Address [1] 3902 0
No.5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.)
Country [1] 3902 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6385 0
Committee of Ethics and Clinical Trial, Chan Gung Memorial Hospital
Ethics committee address [1] 6385 0
No.5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.)
Ethics committee country [1] 6385 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 6385 0
Approval date [1] 6385 0
14/01/2008
Ethics approval number [1] 6385 0

Summary
Brief summary
The current study is to assess the accuracy and impact of a new examination (18F-Fluoride PET/CT) for detecting bony metastasis in cancer patients with high risk of bony metastasis or suspicious/equivocal findings for bony metastasis by conventional studies. The hypothesis to be confirmed in the current study is that the new examination (18F-Fluoride PET/CT) is beneficial for these patients and can give clinical oncologists more accurate diagnosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35063 0
Address 35063 0
Country 35063 0
Phone 35063 0
Fax 35063 0
Email 35063 0
Contact person for public queries
Name 12410 0
Liu, Feng-Yuan
Address 12410 0
Department of Nuclear Medicine
No.5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.)
Country 12410 0
Taiwan, Province Of China
Phone 12410 0
886-3-3281200-2649
Fax 12410 0
Email 12410 0
[email protected]
Contact person for scientific queries
Name 3338 0
Liu, Feng-Yuan
Address 3338 0
Department of Nuclear Medicine
No.5, Fusing St., Gueishan Township, Taoyuan County 333, Taiwan (R.O.C.)
Country 3338 0
Taiwan, Province Of China
Phone 3338 0
886-3-3281200-2649
Fax 3338 0
Email 3338 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.