18F-FDG PET Metabolic Phenotype in Evaluating Therapeutic Response for Breast Cancer Patients With Bone Metastases.
NCT ID: NCT01927939
Last Updated: 2014-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
100 participants
OBSERVATIONAL
2012-10-31
2014-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
FDG PET/CT in Breast Cancer Bone Mets
NCT01996046
18F-NaF PET in Detecting Metastatic Bone Lesion for Patients With Cancer.
NCT00414934
Diagnosis of Bone Metastases in Breast Cancer: Bone Scintigraphy, Fluoride-PET and FDG-PET
NCT01224873
Early Interim 18F-FDG-PET and 18F-FLT-PET for Predicting Treatment Response and Survival in Metastatic Breast Cancer
NCT04411966
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
NCT03544762
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Histological proven breast cancer with bone lesion
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Histological proven breast cancer, with known metastatic bone lesion(s)
3. written informed consent signed
Exclusion Criteria
2. other malignancies known
20 Years
90 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Taiwan University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yen Ruoh Fang, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1023/a:1006308619659.
Roberts CC, Daffner RH, Weissman BN, Bancroft L, Bennett DL, Blebea JS, Bruno MA, Fries IB, Germano IM, Holly L, Jacobson JA, Luchs JS, Morrison WB, Olson JJ, Payne WK, Resnik CS, Schweitzer ME, Seeger LL, Taljanovic M, Wise JN, Lutz ST. ACR appropriateness criteria on metastatic bone disease. J Am Coll Radiol. 2010 Jun;7(6):400-9. doi: 10.1016/j.jacr.2010.02.015.
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.
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.
Galasko CS. Diagnosis of skeletal metastases and assessment of response to treatment. Clin Orthop Relat Res. 1995 Mar;(312):64-75.
Cook GJ, Fogelman I. The role of nuclear medicine in monitoring treatment in skeletal malignancy. Semin Nucl Med. 2001 Jul;31(3):206-11. doi: 10.1053/snuc.2001.23527.
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. doi: 10.1200/JCO.1995.13.5.1123.
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. doi: 10.1111/j.1445-5994.1984.tb03578.x.
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. doi: 10.1200/JCO.2005.00.992. Epub 2005 Feb 28.
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.
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. doi: 10.1200/JCO.2007.11.2854. Epub 2007 Jun 25.
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. doi: 10.1007/s00259-006-0141-3. Epub 2006 Jun 22.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201207002MIB
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.