UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057557 |
|---|---|
| Receipt number | R000065765 |
| Scientific Title | A prospective study to explore the efficacy of brachytherapy using PET/MR for locally advanced cervical cancer |
| Date of disclosure of the study information | 2025/04/08 |
| Last modified on | 2026/04/14 02:14:47 |
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Basic information
Public title
A prospective study to explore the efficacy of brachytherapy using PET/MR for cervical cancer
Acronym
A prospective study to explore the efficacy of brachytherapy using PET/MR for cervical cancer
Scientific Title
A prospective study to explore the efficacy of brachytherapy using PET/MR for locally advanced cervical cancer
Scientific Title:Acronym
A prospective study to explore the efficacy of brachytherapy using PET/MR for cervical cancer
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the efficacy of PET/MR in the diagnosis of tumor localization in brachytherapy for cervical cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in residual tumor volume identified by PET/MR and MR
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
| Device,equipment |
Interventions/Control_1
Performing PET/MR before brachytherapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Histologically confirmed as squamous cell carcinoma, adenosquamous cell carcinoma, or adenocarcinoma
2) Aged 20 years or over
3) Primary tumor involves parametrium, adjacent organ, or uterus
4) Capable of maintaining a supine position
5) No prior radiation therapy to the pelvis
Key exclusion criteria
1) Previous history of hysterectomy
2) Refusal of brachytherapy
3) Fasting blood glucose level of 200 mg/dL or higher
4) Currently using insulin
5) Difficulties in MR imaging due to claustrophobia
6) Presence of metal in the body that is contraindicated for MR imaging
7) The investigator is deemed unsuitable to participate in this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Hiraoka |
Organization
Kyoto University Hospital
Division name
Department of Radiation Oncology
Zip code
606-8507
Address
54, Kawahara-cho, Shogo-in, Sakyo-ku, Kyoto
TEL
+81-75-751-3762
shiraok@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Hiraoka |
Organization
Kyoto University Hospital
Division name
Department of Radiation Oncology
Zip code
606-8507
Address
54, Kawahara-cho, Shogo-in, Sakyo-ku, Kyoto
TEL
+81-75-751-3762
Homepage URL
shiraok@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Shinya Hiraoka
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
+81-75-366-7618
ethcom@kuhp.kyoto-u.ac.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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 08 | Day |
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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 08 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065765
