| Title |
18F-fluoride positron emission tomography/computed tomography and bone scintigraphy for diagnosis of bone metastases in newly diagnosed, high-risk prostate cancer patients: study protocol for a multicentre, diagnostic test accuracy study
|
|---|---|
| Published in |
BMC Cancer, January 2016
|
| DOI | 10.1186/s12885-016-2047-1 |
| Pubmed ID | |
| Authors |
Randi F. Fonager, Helle D. Zacho, Niels C. Langkilde, Lars J. Petersen |
| Abstract |
For decades, planar bone scintigraphy has been the standard practice for detection of bone metastases in prostate cancer and has been endorsed by recent oncology/urology guidelines. It is a sensitive method with modest specificity. (18)F-fluoride positron emission tomography/computed tomography has shown improved sensitivity and specificity over bone scintigraphy, but because of methodological issues such as retrospective design and verification bias, the existing level of evidence with (18)F-fluoride positron emission tomography/computed tomography is limited. The primary objective is to compare the diagnostic properties of (18)F-fluoride positron emission tomography/computed tomography versus bone scintigraphy on an individual patient basis. One hundred forty consecutive, high-risk prostate cancer patients will be recruited from several hospitals in Denmark. Sample size was calculated using Hayen's method for diagnostic comparative studies. This study will be conducted in accordance with recommendations of standards for reporting diagnostic accuracy studies. Eligibility criteria comprise the following: 1) biopsy-proven prostate cancer, 2) PSA ≥50 ng/ml (equals a prevalence of bone metastasis of ≈ 50 % in the study population on bone scintigraphy), 3) patients must be eligible for androgen deprivation therapy, 4) no current or prior cancer (within the past 5 years), 5) ability to comply with imaging procedures, and 6) patients must not receive any investigational drugs. Planar bone scintigraphy and (18)F-fluoride positron emission tomography/computed tomography will be performed within a window of 14 days at baseline. All scans will be repeated after 26 weeks of androgen deprivation therapy, and response of individual lesions will be used for diagnostic classification of the lesions on baseline imaging among responding patients. A response is defined as PSA normalisation or ≥80 % reduction compared with baseline levels, testosterone below castration levels, no skeletal related events, and no clinical signs of progression. Images are read by blinded nuclear medicine physicians. The protocol is currently recruiting. To the best of our knowledge, this is one of the largest prospective studies comparing (18)F-fluoride positron emission tomography/computed tomography and bone scintigraphy. It is conducted in full accordance with recommendations for diagnostic accuracy trials. It is intended to provide valid documentation for the use of (18)F-fluoride positron emission tomography/computed tomography for examination of bone metastasis in the staging of prostate cancer. |
X Demographics
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Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Dominican Republic | 2 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 2 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 31 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| China | 1 | 3% |
| Unknown | 30 | 97% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 7 | 23% |
| Student > Bachelor | 5 | 16% |
| Student > Master | 4 | 13% |
| Lecturer | 2 | 6% |
| Other | 2 | 6% |
| Other | 6 | 19% |
| Unknown | 5 | 16% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 12 | 39% |
| Biochemistry, Genetics and Molecular Biology | 2 | 6% |
| Agricultural and Biological Sciences | 2 | 6% |
| Engineering | 2 | 6% |
| Mathematics | 1 | 3% |
| Other | 4 | 13% |
| Unknown | 8 | 26% |
Attention Score in Context
This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 08 February 2016.
All research outputs
#14,703,975
of 22,837,982 outputs
Outputs from BMC Cancer
#3,626
of 8,312 outputs
Outputs of similar age
#216,874
of 394,936 outputs
Outputs of similar age from BMC Cancer
#72
of 179 outputs
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