Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414934
Status:
UNKNOWN
Last Update Posted:
2009-08-17
First Post:
2006-12-21
Brief Title:
18F-NaF PET in Detecting Metastatic Bone Lesion for Patients With Cancer
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Effectiveness of Whole-body 18F-NaF PET in Detecting Metastatic Bone Lesion for Patients With Cancer A Comparison Study With 99mTc-MDP Bone Scintigraphy
Status:
UNKNOWN
Status Verified Date:
2009-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
18F ion is a positron emitting bone radiopharmaceuticals The skeletal uptake of 18F relies on the exchange of hydroxyl ions in the hydroxyapatit crystal which is an indicator of bone metabolic activity 8 It has good soft tissue clearance and high affinity of to the bone matrix It is able to perform a highly sensitive whole-body screening for bone metastases using a high resolution PET scanner Therefore we conduct a prospective study to evaluate the accuracy and clinical value of 18F PET in staging bone metastases by
1 Comparing the sensitivity of 18F-NaF PET with that of 99mTc-MDP scintigraphy
2 Determining the clinical impact of PET results on subsequent patient management
1 Comparing the sensitivity of 18F-NaF PET with that of 99mTc-MDP scintigraphy
2 Determining the clinical impact of PET results on subsequent patient management
Detailed Description:
Skeletal metastases are the most common cause of morbidity and mortality in patients with malignancy especially in patients with breast cancer lung cancer prostate cancer and head neck cancer In patients with lung cancer bone metastases are present in 20-30 of patient at initial diagnosis 1-2 Accuracy staging bone metastases can lead to modification of following treatment and evaluation of prognosis
The planar whole-body 99mTc-methylene diphosphonate MDP radionuclide bone scintigraphy is the most widely used technique in detecting metastatic bone lesions at present Abnormal tracer accumulation may occur at any skeletal site with an elevated rate of bone turnover However conventional planar bone scintigraphy was reported to be less sensitive than MRI in detecting spinal metastases 3-7
18F ion is a positron emitting bone radiopharmaceuticals The skeletal uptake of 18F relies on the exchange of hydroxyl ions in the hydroxyapatit crystal which is an indicator of bone metabolic activity 8 It has good soft tissue clearance and high affinity of to the bone matrix It is able to perform a highly sensitive whole-body screening for bone metastases using a high resolution PET scanner
To the best of our knowledge there are only limited studies evaluating the clinical utilization of 18F-NaF PET for detection of bone metastases 10-12 Therefore we would like to conduct a prospective study to evaluate the accuracy and clinical value of 18F PET in staging bone metastases by
1 Comparing the sensitivity of 18F-NaF PET with that of 99mTc-MDP scintigraphy
2 Determining the clinical impact of PET results on subsequent patient management
99mTc-MDP scintigraphy and 18F PET will be performed in 2 weeks for all patients Interpretation of 99mTc-MDP scintigraphy and 18F PET will be performed following the criteria described by Crasnow et all 13 The accuracy of 99mTc-MDP scintigraphy and 18F PET detection of bone metastases for each patient will be determined by the histopathological results MRI results or other clinical evidences afterward
The planar whole-body 99mTc-methylene diphosphonate MDP radionuclide bone scintigraphy is the most widely used technique in detecting metastatic bone lesions at present Abnormal tracer accumulation may occur at any skeletal site with an elevated rate of bone turnover However conventional planar bone scintigraphy was reported to be less sensitive than MRI in detecting spinal metastases 3-7
18F ion is a positron emitting bone radiopharmaceuticals The skeletal uptake of 18F relies on the exchange of hydroxyl ions in the hydroxyapatit crystal which is an indicator of bone metabolic activity 8 It has good soft tissue clearance and high affinity of to the bone matrix It is able to perform a highly sensitive whole-body screening for bone metastases using a high resolution PET scanner
To the best of our knowledge there are only limited studies evaluating the clinical utilization of 18F-NaF PET for detection of bone metastases 10-12 Therefore we would like to conduct a prospective study to evaluate the accuracy and clinical value of 18F PET in staging bone metastases by
1 Comparing the sensitivity of 18F-NaF PET with that of 99mTc-MDP scintigraphy
2 Determining the clinical impact of PET results on subsequent patient management
99mTc-MDP scintigraphy and 18F PET will be performed in 2 weeks for all patients Interpretation of 99mTc-MDP scintigraphy and 18F PET will be performed following the criteria described by Crasnow et all 13 The accuracy of 99mTc-MDP scintigraphy and 18F PET detection of bone metastases for each patient will be determined by the histopathological results MRI results or other clinical evidences afterward
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None