Breast CancerNCT01927939
18F-FDG PET Metabolic Phenotype in Evaluating Therapeutic Response for Breast Cancer Patients With Bone Metastases.
An observational study of Breast Cancer and 18F-FDG PET, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years, women only
- Conditions the study is for
- Breast Cancer, 18F-FDG PET
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2012to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Histological proven breast cancer, with known metastatic bone lesion(s)
Who may be able to join
- Age：20-90 years old
- Histological proven breast cancer, with known metastatic bone lesion(s)
- written informed consent signed
Who cannot join
- pregnant or intend to be pregnant
- other malignancies known
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Yen Ruoh Fang, M.D., Ph.D., 886-2-23123456 ext. 65581, rfyen@ntu.edu.tw
Yen Ruoh Fang, M.D., Ph.D.
About this study
Official title: The Effectiveness of 18F-FDG PET Metabolic Phenotype in Evaluating Therapeutic Response for Breast Cancer Patients With Bone Metastases.
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.
Read the detailed 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.
- Conditions
- Breast Cancer, 18F-FDG PET
- Keywords
- Breast cancer; bone metastases; 18F-FDG PET; 99mTc bone scintigraphy; therapy response monitoring; prognosis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Histological proven breast cancer with bone lesion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The uptake of 18F-FDG PET.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startOct 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yen Ruoh Fang, M.D.,Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927939
- Sponsor's protocol ID
- 201207002MIB
- Status last verified
- Apr 2014
- First submitted
- 16 Aug 2013
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10832597Roberts 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.
PubMed 20522392Houssami 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.
PubMed 21896542Vassiliou 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.
PubMed 21530193Galasko CS. Diagnosis of skeletal metastases and assessment of response to treatment. Clin Orthop Relat Res. 1995 Mar;(312):64-75.
PubMed 7634619Cook 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.
PubMed 11430527Vogel 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.
PubMed 7537797Rossleigh 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.
PubMed 6235799Mitsudomi 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.
PubMed 15738541Tateishi 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.
PubMed 18372468Du 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.
PubMed 17592153Israel 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.
PubMed 16791597De 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.
PubMed 20660382
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of 18F-FDG PET Metabolic Phenotype in Evaluating Therapeutic Response for Breast Cancer Patients With Bone Metastases.
- ClinicalTrials.gov ID
- NCT01927939
- Acronym / sponsor ID
- 201207002MIB
- Conditions
- Breast Cancer, 18F-FDG PET
- Keywords
- Breast cancer; bone metastases; 18F-FDG PET; 99mTc bone scintigraphy; therapy response monitoring; prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Histological proven breast cancer with bone lesion | – | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histological proven breast cancer, with known metastatic bone lesion(s)
Key inclusion criteria (3 listed)
- Age：20-90 years old
- Histological proven breast cancer, with known metastatic bone lesion(s)
- written informed consent signed
Key exclusion criteria (2 listed)
- pregnant or intend to be pregnant
- other malignancies known
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The uptake of 18F-FDG PET.
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Background: PubMed 10832597Solomayer 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.
- Background: PubMed 20522392Roberts 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.
- Background: PubMed 21896542Houssami 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.
- Background: PubMed 21530193Vassiliou 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.
- Background: PubMed 7634619Galasko CS. Diagnosis of skeletal metastases and assessment of response to treatment. Clin Orthop Relat Res. 1995 Mar;(312):64-75.
- Background: PubMed 11430527Cook 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.
- Background: PubMed 7537797Vogel 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.
- Background: PubMed 6235799Rossleigh 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.
- Background: PubMed 15738541Mitsudomi 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.
- Background: PubMed 18372468Tateishi 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.
- Background: PubMed 17592153Du 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.
- Background: PubMed 16791597Israel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen Ruoh Fang, M.D.,Ph.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and 18F-FDG PET, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yen Ruoh Fang, M.D.,Ph.D. (886-2-23123456 ext. 65581, rfyen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The uptake of 18F-FDG PET. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01927939, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2014.