UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000041653 |
| Receipt No. | R000047544 |
| Scientific Title | FDG PET/CT for the diagnosis in rectal cancer |
| Date of disclosure of the study information | 2020/09/05 |
| Last modified on | 2020/09/02 (Ver. 1) |
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| Basic information | ||
| Public title | FDG PET/CT for the diagnosis in rectal cancer | |
| Acronym | FDG PET/CT for rectal cancer | |
| Scientific Title | FDG PET/CT for the diagnosis in rectal cancer | |
| Scientific Title:Acronym | FDG PET/CT for rectal cancer | |
| Region |
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| Condition | ||||
| Condition | Rectal cancer | |||
| Classification by specialty |
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| Classification by malignancy | Malignancy | |||
| Genomic information | NO | |||
| Objectives | |
| Narrative objectives1 | To evaluate the efficacy for the tumor staging and predicting prognosis in rectal cancer |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Diagnostic accuracy for tumor stating |
| Key secondary outcomes | The efficacy for predicting prognosis |
| Base | |
| Study type | Observational |
| Study design | |
| Basic design | |
| Randomization | |
| Randomization unit | |
| Blinding | |
| Control | |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | |
| No. of arms | |
| Purpose of intervention | |
| Type of intervention | |
| Interventions/Control_1 | |
| 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 | Pathologically proven rectal cancer | |||
| Key exclusion criteria | Uncontrolled diabetes
Not adenocarcinoma |
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| Target sample size | 100 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | National Center for Global Health and Medicine | ||||||
| Division name | Nuclear Meicine | ||||||
| Zip code | 162-8655 | ||||||
| Address | Toyama 1-21-1, Shinjuku-ku, Tokyo | ||||||
| TEL | 03-3202-7181 | ||||||
| mhotta@hosp.ncgm.go.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | National Center for Global Health and Medicine | ||||||
| Division name | Nuclear Medicine | ||||||
| Zip code | 162-8655 | ||||||
| Address | Toyama 1-21-1, Shinjuku-ku, Tokyo | ||||||
| TEL | 03-3202-7181 | ||||||
| Homepage URL | |||||||
| mhotta@hosp.ncgm.go.jp | |||||||
| Sponsor | |
| Institute | National Center for Global Health and Medicine |
| Institute | |
| Department | |
| Funding Source | |
| Organization | None |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | National Center for Global Health and Medicine |
| Address | Toyama 1-21-1, Shinjuku-ku, Tokyo |
| Tel | 03-3202-7181 |
| kenkyu-shinsa@hosp.ncgm.go.jp | |
| 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 | https://cancerimagingjournal.biomedcentral.com/articles/10.1186/s40644-018-0137-9 |
| Publication of results | Partially published |
| Result | |||||||
| URL related to results and publications | https://cancerimagingjournal.biomedcentral.com/articles/10.1186/s40644-018-0137-9 | ||||||
| Number of participants that the trial has enrolled | 59 | ||||||
| Results | FDG PET/CT was able to diagnose lymph node metastasis more accurately than MRI. |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | The patients with rectal cancer who underwent FDG PET/CT |
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| Participant flow | The patients underwent surgery after PET. |
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| Adverse events | None |
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| Outcome measures | The efficacy for the tumor staging |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| 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 | Retrospective observational cohort study |
| 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=R000047544 |
