NCT00414934

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 17, 2009

Status Verified

August 1, 2009

Enrollment Period

4.2 years

First QC Date

December 21, 2006

Last Update Submit

August 13, 2009

Conditions

Keywords

cancerbone scanNaF bone PET

Study Arms (1)

metastatic bone lesion for patients with cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

metastatic bone lesion for patients with cancer

You may qualify if:

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

You may not qualify if:

  • patients whose age are below 18
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (13)

  • 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. doi: 10.1002/1097-0142(19890215)63:43.0.co;2-f.

    PMID: 2536586BACKGROUND
  • 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. doi: 10.1002/1097-0142(19861015)58:83.0.co;2-v.

    PMID: 3019512BACKGROUND
  • 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. doi: 10.1097/00004728-198907000-00008.

    PMID: 2745777BACKGROUND
  • 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. doi: 10.1097/00003072-199403000-00005.

    PMID: 8033466BACKGROUND
  • Thrupkaew AK, Henkin RE, Quinn JL 3rd. False negative bone scans in disseminated metastatic disease. Radiology. 1974 Nov;113(2):383-6. doi: 10.1148/113.2.383. No abstract available.

    PMID: 4419062BACKGROUND
  • 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. doi: 10.1007/BF00173484.

    PMID: 8287874BACKGROUND
  • 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. doi: 10.2214/ajr.155.5.2120933.

    PMID: 2120933BACKGROUND
  • 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.

    PMID: 1569473BACKGROUND
  • 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. doi: 10.1200/JCO.1999.17.8.2381.

    PMID: 10561300BACKGROUND
  • 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.

    PMID: 10520701BACKGROUND
  • 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.

    PMID: 11752076BACKGROUND
  • 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. doi: 10.1359/jbmr.2003.18.12.2206.

    PMID: 14672356BACKGROUND
  • 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. doi: 10.1016/s0001-2998(97)80043-8.

    PMID: 9144855BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ruoh-Fang Yen, M.D.,Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Study Start

October 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 17, 2009

Record last verified: 2009-08

Locations