Unique ID issued by UMIN | UMIN000027331 |
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Receipt number | R000031319 |
Scientific Title | Clarification of action mechanism of Halaven (Eribulin) using MRI |
Date of disclosure of the study information | 2017/05/15 |
Last modified on | 2022/11/20 15:43:01 |
Clarification of action mechanism of Halaven (Eribulin) using MRI
Clarification of action mechanism of Halaven using MRI
Clarification of action mechanism of Halaven (Eribulin) using MRI
Clarification of action mechanism of Halaven using MRI
Japan |
breast cancer
Breast surgery | Radiology | Adult |
Malignancy
NO
To observe effect of Halaven on tumor microperfusion
Pharmacodynamics
Exploratory
Pragmatic
Not applicable
Perfusion of tumor before, 8 days-, 29 days-, 90 days- after start of Halaven treatment
ADC and size of tumor before, 8 days-, 29 days-, 90 days- after start of Halaven treatment
Observational
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1. Advanced or metastatic breast cancer patients who are to be treated with Halaven at Tokai University Hospital
2. Patients with measurable lesions by contrast-enhanced MRI; lymph node metastasis, liver metastasis, or osteolytic bone metastasis with shortest dimension larger than 2cm.
3. Patients who can hold breath for 20 seconds and can follow instruction during MR examinations.
4. Patients who give written informed consent for this study.
1.Patients with concomitant radiation therapy for the target lesions.
2.Allergy to Gd-contrast.
3.Patients with asthma
4.Patients with renal dysfunction
5.Pregnant or breast feeding
6.Implanted metallic or electronic device not confirmed safety at 3T-MRI.
7.Patients with difficult venous access.
10
1st name | Toshiki |
Middle name | |
Last name | Kazama |
Tokai University Hospital
Department of Diagnostic Radiology
259-1193
143 Shimo-Kasuya, Isehara, 259-1193, Japan
0463-93-1121
kazamat@fg7.so-net.ne.jp
1st name | Toshiki |
Middle name | |
Last name | Kazama |
Tokai University Hospital
Department of Diagnostic Radiology
259-1193
143 Shimo-Kasuya, Isehara, 259-1193, Japan
0463-93-1121
kazamat@fg7.so-net.ne.jp
Tokai University Hospital
Tokai University Hospital
Self funding
Institutional Review Board for Clinical Research, Tokai University
143 Shimo-Kasuya, Isehara, 259-1193, Japan
0463-93-1121
tokai-rinsho@ml.tokai-u.jp
NO
東海大学医学部附属病院(神奈川県)
2017 | Year | 05 | Month | 15 | Day |
Unpublished
Terminated
2017 | Year | 03 | Month | 16 | Day |
2017 | Year | 03 | Month | 18 | Day |
2017 | Year | 05 | Month | 17 | Day |
2022 | Year | 03 | Month | 31 | Day |
1. Pretreatment evaluation: contrast-enhanced MRI.
2. Eight days after start of Halaven treatment: contrast-enhanced MRI
3. Twenty-nine days after start of Halaven treatment: contrast-enhanced MRI
4. Approximately 90 days after start of Halaven treatment, or soon after judgment of PD: contrast-enhanced MRI
2017 | Year | 05 | Month | 13 | Day |
2022 | Year | 11 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031319
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