Unique ID issued by UMIN | UMIN000010749 |
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Receipt number | R000012561 |
Scientific Title | Evaluation of the utility of bone scan index (BSI) in the prediction of therapeutic effect of breast cancer patient with bone metastasis treated by zoledronic acid |
Date of disclosure of the study information | 2013/05/20 |
Last modified on | 2013/05/17 13:59:21 |
Evaluation of the utility of bone scan index (BSI) in the prediction of therapeutic effect of breast cancer patient with bone metastasis treated by zoledronic acid
Therapeutic effect evaluation of breast cancer patient with bone metastasis treated by zoledronic acid using BSI
Evaluation of the utility of bone scan index (BSI) in the prediction of therapeutic effect of breast cancer patient with bone metastasis treated by zoledronic acid
Therapeutic effect evaluation of breast cancer patient with bone metastasis treated by zoledronic acid using BSI
Japan |
Breast cancer patient with bone metastais
Breast surgery | Radiology |
Malignancy
NO
The purpose is to evaluate the relationship between the incidence of skeletal related events (SRE) and the change rate of the BSI, targeting to the breast cancer patient with bone metastasis treated by zoledronic acid.
Efficacy
Confirmatory
Explanatory
The significant difference of the average rates of the BSI change before and after administration of zoledronic acid between two groups with and without SRE is evaluated using non-paired t test .
(1) Correlation of BSI and bone metabolism markers (BAP, TRAP-5b, I-CTP)
(2) Correlation of local BSI change rate and the height of vertebral bodies
(3) Correlation SRE and BSI change rate in two groups with and without the effect of systemic therapy
Observational
20 | years-old | <= |
80 | years-old | >= |
Female
1) Patient who undewent bone scintigraphy
2) Patient with more than 1 bone metastasis
3) Patient older than 20 years old
4) Patients with Performance Status (PS, ECOG classification) 0 to 2 (If PS3 and 4 is due to only bone metastasis, it can be included )
5) Breast cancer patient with scheduled Zoledronic acid treatment
6) Patient with preserved major organ function as shown below,
WBC: more than 3,000/mm3 or Neutrophil more than 1,500/mm3
Hb (Hemoglobin): more than 9.0g
Plt (Platelet): more than 100,000/mm3
T-Bil (Total serum bilirubin): Less than 1.5 times of normal limit in each institute
AST and ALT: Less than 2.5 times of normal limit in each institute
Serum creatinine: less than 2.0mg/dL
Serum calcium: more than 8.0mg/dL (and less than 12.0mg/dL)
Corrected Calcium (mg/dL)=measured serum calcium - Serum albumin (g/gL)+4
7) Patients with no abnormality in oral investigation
8) Patients who offered written informed consent
1) Patient with pregnancy, suspected pregnancy and breast feeding
2) Patient with difficulty in bone scintigraphy data analsysis due to the structural deformity or extraosseous uptake in bone scintigraphy
3) Patient with hypersensitivity to the element of zoredronic acid or bisphosphonate
4) Patient with renal dysfunction
5) Patient with active double cancer
6) Patient with severe underlying disease
7) Patient who need to be invasively treated due to infectious disorder of teeth and jawbone
8) Patient who underwent invasive dental treatment in the past three months
9) Patient who was treated by other bisphosphonate
10) Patient who was judged by medical doctor as inappropriate for this study
40
1st name | |
Middle name | |
Last name | Tetsuya Higuchi |
Gunma University Graduate School of Medicine
Diagnostic Radiology and Nuclear Medicine
3-39-22 Showamachi Maebashi, Gunma
027-220-8401
1st name | |
Middle name | |
Last name |
Gunma University Graduate School of Medicine
Diagnostic Radiology and Nuclear Medicine
Gunma University
Gunma University
Self funding
NO
2013 | Year | 05 | Month | 20 | Day |
Unpublished
Preinitiation
2013 | Year | 05 | Month | 01 | Day |
2013 | Year | 05 | Month | 20 | Day |
2018 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
Observational study
2013 | Year | 05 | Month | 17 | Day |
2013 | Year | 05 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012561
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