18F-FDG PET Metabolic Phenotype in Evaluating Therapeutic Response for Breast Cancer Patients With Bone Metastases.

Breast Cancer Clinical Trial

Official title:

The Effectiveness of 18F-FDG PET Metabolic Phenotype in Evaluating Therapeutic Response for Breast Cancer Patients With Bone Metastases.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01927939
• Other study ID #: 201207002MIB
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2013
• Last updated: April 13, 2014
• Start date: October 2012
• Est. completion date: August 2014

Study information

• Verified date: April 2014
• Source: National Taiwan University Hospital
• Contact: Yen Ruoh Fang, M.D.,Ph.D.
• Phone: 886-2-23123456
• Email: rfyen[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

This study is to evaluate the effectiveness of 18F-FDG PET in following up of metastastic bone lesions and in predicting outcome for breast cancer patients after therapy.

Primary outcome: Using 18F-FDG uptake to evaluate the metastatic bone status after treatment. The PET results will be compared with the results in Tc-99m MDP bone scintigraphy.

Secondary outcome: Evaluate the relationship between the 18F-FDG uptake of the metastatic bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.

Description:

Background: Although 99mTc MDP bone scintigraphy is a sensitive tool for screening metastatic bone status, it is not a satisfactory imaging modality in evaluating residual disease after therapy. 18F-FDG PET has been an effective imaging tool for many malignancies including breast cancer, not only in diagnosis and staging, but also in monitoring response and following up disease status after therapy.

Purpose: This study is to evaluate the effectiveness of 18F-FDG PET in following up of metastastic bone lesions and in predicting outcome for breast cancer patients after therapy.

Method: Breast cancer patients with bone metastases, age 20-90 year-old, will be included in this study.

Primary outcome: Using 18F-FDG uptake to evaluate the metastatic bone status after treatment. The PET results will be compared with the results in Tc-99m MDP bone scintigraphy.

Secondary outcome: Evaluate the relationship between the 18F-FDG uptake of the metastatic bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age:20-90 years old

2. Histological proven breast cancer, with known metastatic bone lesion(s)

3. written informed consent signed

Exclusion Criteria:

1. pregnant or intend to be pregnant

2. other malignancies known

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• 18F-FDG PET
• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (13)

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De Giorgi U, Mego M, Rohren EM, Liu P, Handy BC, Reuben JM, Macapinlac HA, Hortobagyi GN, Cristofanilli M, Ueno NT. 18F-FDG PET/CT findings and circulating tumor cell counts in the monitoring of systemic therapies for bone metastases from breast cancer. J Nucl Med. 2010 Aug;51(8):1213-8. doi: 10.2967/jnumed.110.076455. Epub 2010 Jul 21. — View Citation

Du Y, Cullum I, Illidge TM, Ell PJ. Fusion of metabolic function and morphology: sequential [18F]fluorodeoxyglucose positron-emission tomography/computed tomography studies yield new insights into the natural history of bone metastases in breast cancer. J Clin Oncol. 2007 Aug 10;25(23):3440-7. Epub 2007 Jun 25. — View Citation

Galasko CS. Diagnosis of skeletal metastases and assessment of response to treatment. Clin Orthop Relat Res. 1995 Mar;(312):64-75. Review. — View Citation

Houssami N, Costelloe CM. Imaging bone metastases in breast cancer: evidence on comparative test accuracy. Ann Oncol. 2012 Apr;23(4):834-43. doi: 10.1093/annonc/mdr397. Epub 2011 Sep 6. Review. — View Citation

Israel O, Goldberg A, Nachtigal A, Militianu D, Bar-Shalom R, Keidar Z, Fogelman I. FDG-PET and CT patterns of bone metastases and their relationship to previously administered anti-cancer therapy. Eur J Nucl Med Mol Imaging. 2006 Nov;33(11):1280-4. Epub 2006 Jun 22. — View Citation

Mitsudomi T, Kosaka T, Endoh H, Horio Y, Hida T, Mori S, Hatooka S, Shinoda M, Takahashi T, Yatabe Y. Mutations of the epidermal growth factor receptor gene predict prolonged survival after gefitinib treatment in patients with non-small-cell lung cancer with postoperative recurrence. J Clin Oncol. 2005 Apr 10;23(11):2513-20. Epub 2005 Feb 28. — View Citation

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Rossleigh MA, Lovegrove FT, Reynolds PM, Byrne MJ, Whitney BP. The assessment of response to therapy of bone metastases in breast cancer. Aust N Z J Med. 1984 Feb;14(1):19-22. — View Citation

Solomayer EF, Diel IJ, Meyberg GC, Gollan C, Bastert G. Metastatic breast cancer: clinical course, prognosis and therapy related to the first site of metastasis. Breast Cancer Res Treat. 2000 Feb;59(3):271-8. — View Citation

Tateishi U, Gamez C, Dawood S, Yeung HW, Cristofanilli M, Macapinlac HA. Bone metastases in patients with metastatic breast cancer: morphologic and metabolic monitoring of response to systemic therapy with integrated PET/CT. Radiology. 2008 Apr;247(1):189-96. doi: 10.1148/radiol.2471070567. — View Citation

Vassiliou V, Andreopoulos D, Frangos S, Tselis N, Giannopoulou E, Lutz S. Bone metastases: assessment of therapeutic response through radiological and nuclear medicine imaging modalities. Clin Oncol (R Coll Radiol). 2011 Nov;23(9):632-45. doi: 10.1016/j.clon.2011.03.010. Epub 2011 Apr 29. Review. — View Citation

Vogel CL, Schoenfelder J, Shemano I, Hayes DF, Gams RA. Worsening bone scan in the evaluation of antitumor response during hormonal therapy of breast cancer. J Clin Oncol. 1995 May;13(5):1123-8. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The uptake of 18F-FDG PET.		2 hours	No