UMIN-CTR Clinical Trial
| Recruitment status | Terminated |
| Unique ID issued by UMIN | UMIN000029770 |
| Receipt No. | R000034012 |
| Scientific Title | Detection and evaluation of sentinel lymph nodes and its blood flows with contrast-enhanced ultrasonography in oropharyngeal cancers -a phase I study- |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/05/10 (Ver. 4) |
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| Basic information | ||
| Public title | Detection and evaluation of sentinel lymph nodes and its blood flows with contrast-enhanced ultrasonography in oropharyngeal cancers -a phase I study- | |
| Acronym | Detection of sentinel lymph nodes with ultrasonography in oropharyngeal cancers, a phase I study | |
| Scientific Title | Detection and evaluation of sentinel lymph nodes and its blood flows with contrast-enhanced ultrasonography in oropharyngeal cancers -a phase I study- | |
| Scientific Title:Acronym | Detection of sentinel lymph nodes with ultrasonography in oropharyngeal cancers, a phase I study | |
| Region |
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| Condition | ||
| Condition | Oropgaryngeal Cancer | |
| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | Adverse Events |
| Basic objectives2 | Safety |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Adverse events due to ultrasonography with sonazoid, SN detection rate |
| Key secondary outcomes | |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Single arm |
| Randomization | Non-randomized |
| Randomization unit | |
| Blinding | Open -no one is blinded |
| Control | Uncontrolled |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | ||
| No. of arms | 1 | |
| Purpose of intervention | Diagnosis | |
| Type of intervention |
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| Interventions/Control_1 | Detection of SN and its blood flow with contrast enhanced ultrasonography | |
| Interventions/Control_2 | ||
| Interventions/Control_3 | ||
| Interventions/Control_4 | ||
| Interventions/Control_5 | ||
| Interventions/Control_6 | ||
| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | 1) cNo with CT and/or US
2) No history for treatment of oropharyngeal cancer 3) 18 years old or older 4) written informed consent |
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| Key exclusion criteria | 1) Recurrent cases
2) history of irradiation for neck disease 3) history of treatment before surgery of this time 4) allergy for sonazoid 5) allergy for egg 6) pregnancy 7) Doctors did no approve the continuing the study |
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| Target sample size | 10 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
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| Organization | Knazawa University Hospital | ||||||
| Division name | Otolaryngology, and Head & Neck Surgery | ||||||
| Zip code | |||||||
| Address | 13-1 Takara-machi, Kanazawa | ||||||
| TEL | 076-265-2413 | ||||||
| jibiinnfo@med.kanazawa-u.ac.jp | |||||||
| Public contact | |||||||
| 1st name of contact person |
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| Organization | Knazawa University Hospital | ||||||
| Division name | Otolaryngology, and Head & Neck Surgery | ||||||
| Zip code | |||||||
| Address | 13-1 Takara-machi, Kanazawa | ||||||
| TEL | 076-265-2413 | ||||||
| Homepage URL | |||||||
| jibiinnfo@med.kanazawa-u.ac.jp | |||||||
| Sponsor | |
| Institute | Knazawa University Hospital |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Kanazawa University Hospital |
| Organization | |
| Division | |
| Category of Funding Organization | Other |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | |
| Address | |
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| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
| Institutions | |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | |
| Publication of results | Unpublished |
| Result | |
| URL related to results and publications | |
| Number of participants that the trial has enrolled | |
| Results | Sentinel lymph nodes were detected in three out of four cases. |
| Results date posted | |
| Results Delayed | |
| Results Delay Reason | |
| Date of the first journal publication of results | |
| Baseline Characteristics | |
| Participant flow | |
| Adverse events | |
| Outcome measures | |
| Plan to share IPD | |
| IPD sharing Plan description | |
| Progress | |||||||
| Recruitment status | Terminated | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | Transferred to the other data base |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034012 |
