18F-NaF PET in Detecting Metastatic Bone Lesion for Patients With Cancer. - Full Text View

Purpose

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

Comparing the sensitivity of 18F-NaF PET with that of 99mTc-MDP scintigraphy;
Determining the clinical impact of PET results on subsequent patient management.

Condition
Cancer

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Nuclear Scans

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment:	100
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
metastatic bone lesion for patients with cancer

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

Comparing the sensitivity of 18F-NaF PET with that of 99mTc-MDP scintigraphy;
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

metastatic bone lesion for patients with cancer

Criteria

Inclusion Criteria:

pathology proofed lung cancer and are referred to perform whole-body bone scintigraphies for staging metastatic bone diseases

Exclusion Criteria:

patients whose age are below 18
pregnant women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414934

Contacts

Contact: Ruoh-Fang Yen, M.D.,Ph.D.

886-2-23123456 ext 5581

rfyen@ha.mc.ntu.edu.tw

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan, 100
Contact: Ruoh-Fang Yen, M.D., Ph.D. 886-2-23123456 ext 5581 rfyen@ha.mc.ntu.edu.tw
Principal Investigator: Ruoh-Fang Yen, M.D., Ph.D.

Sponsors and Collaborators

National Taiwan University Hospital

Far Eastern Memorial Hospital

Investigators

Principal Investigator:

Ruoh-Fang Yen, M.D.,Ph.D.

National Taiwan University Hospital

More Information

Publications:

Tritz DB, Doll DC, Ringenberg QS, Anderson S, Madsen R, Perry MC, Yarbro JW. Bone marrow involvement in small cell lung cancer. Clinical significance and correlation with routine laboratory variables. Cancer. 1989 Feb 15;63(4):763-6.

Bezwoda WR, Lewis D, Livini N. Bone marrow involvement in anaplastic small cell lung cancer. Diagnosis, hematologic features, and prognostic implications. Cancer. 1986 Oct 15;58(8):1762-5.

Avrahami E, Tadmor R, Dally O, Hadar H. Early MR demonstration of spinal metastases in patients with normal radiographs and CT and radionuclide bone scans. J Comput Assist Tomogr. 1989 Jul-Aug;13(4):598-602.

Brown B, Laorr A, Greenspan A, Stadalnik R. Negative bone scintigraphy with diffuse osteoblastic breast carcinoma metastases. Clin Nucl Med. 1994 Mar;19(3):194-6.

Thrupkaew AK, Henkin RE, Quinn JL 3rd. False negative bone scans in disseminated metastatic disease. Radiology. 1974 Nov;113(2):383-6. No abstract available.

Haubold-Reuter BG, Duewell S, Schilcher BR, Marincek B, von Schulthess GK. The value of bone scintigraphy, bone marrow scintigraphy and fast spin-echo magnetic resonance imaging in staging of patients with malignant solid tumours: a prospective study. Eur J Nucl Med. 1993 Nov;20(11):1063-9.

Frank JA, Ling A, Patronas NJ, Carrasquillo JA, Horvath K, Hickey AM, Dwyer AJ. Detection of malignant bone tumors: MR imaging vs scintigraphy. AJR Am J Roentgenol. 1990 Nov;155(5):1043-8.

Hawkins RA, Choi Y, Huang SC, Hoh CK, Dahlbom M, Schiepers C, Satyamurthy N, Barrio JR, Phelps ME. Evaluation of the skeletal kinetics of fluorine-18-fluoride ion with PET. J Nucl Med. 1992 May;33(5):633-42.

Schirrmeister H, Guhlmann A, Kotzerke J, Santjohanser C, Kuhn T, Kreienberg R, Messer P, Nussle K, Elsner K, Glatting G, Trager H, Neumaier B, Diederichs C, Reske SN. Early detection and accurate description of extent of metastatic bone disease in breast cancer with fluoride ion and positron emission tomography. J Clin Oncol. 1999 Aug;17(8):2381-9.

Schirrmeister H, Guhlmann A, Elsner K, Kotzerke J, Glatting G, Rentschler M, Neumaier B, Trager H, Nussle K, Reske SN. Sensitivity in detecting osseous lesions depends on anatomic localization: planar bone scintigraphy versus 18F PET. J Nucl Med. 1999 Oct;40(10):1623-9.

Schirrmeister H, Glatting G, Hetzel J, Nussle K, Arslandemir C, Buck AK, Dziuk K, Gabelmann A, Reske SN, Hetzel M. Prospective evaluation of the clinical value of planar bone scans, SPECT, and (18)F-labeled NaF PET in newly diagnosed lung cancer. J Nucl Med. 2001 Dec;42(12):1800-4.

Hetzel M, Arslandemir C, Konig HH, Buck AK, Nussle K, Glatting G, Gabelmann A, Hetzel J, Hombach V, Schirrmeister H. F-18 NaF PET for detection of bone metastases in lung cancer: accuracy, cost-effectiveness, and impact on patient management. J Bone Miner Res. 2003 Dec;18(12):2206-14.

Krasnow AZ, Hellman RS, Timins ME, Collier BD, Anderson T, Isitman AT. Diagnostic bone scanning in oncology. Semin Nucl Med. 1997 Apr;27(2):107-41. Review.

Responsible Party:	Yen RF, National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00414934 History of Changes
Other Study ID Numbers:	941220
Study First Received:	December 21, 2006
Last Updated:	August 13, 2009
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

cancer
bone scan
NaF bone PET

ClinicalTrials.gov processed this record on May 19, 2013