UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037493 |
|---|---|
| Receipt number | R000042702 |
| Scientific Title | The Prognostic Value of 18F-FDG PET/CT Taken Immediately After Completion of Radiotherapy for Lung Cancer Treated with Concurrent Chemoradiotherapy: A Pilot Study |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2025/01/27 16:49:22 |
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Basic information
Public title
The Prognostic Value of 18F-FDG PET/CT Taken Immediately After Completion of Radiotherapy for Lung Cancer Treated with Concurrent Chemoradiotherapy: A Pilot Study
Acronym
PET/CT immediately following Lung CCRT
Scientific Title
The Prognostic Value of 18F-FDG PET/CT Taken Immediately After Completion of Radiotherapy for Lung Cancer Treated with Concurrent Chemoradiotherapy: A Pilot Study
Scientific Title:Acronym
PET/CT immediately following Lung CCRT
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the prognostic value of 18F- fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) taken immediately after completion of radiotherapy in lung cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the SUVmax of PET/CT taken within 24hours of completing radiotherapy and PET/CT taken 2-9 month after completing radiotherapy and assessing the efficacy of PET/CT taken immediately after completion of radiotherapy.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Taking PET/CT within 24hours of completion of radiotherapy which is usually done later than 2month after completion of radiotherapy.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Have a primary lung cancer diagnosis based on histology
(2) Are planned to receive curative-intent concurrent chemoradiotherapy treatment;
(3) Have provided consent of being discharged on the last day of RT to take PET/CT within 24 hours.
Key exclusion criteria
Patients who have a history of radiotherapy to the chest
Patients with recurrent lung cancer.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Anneyuko |
| Middle name | Ikeda |
| Last name | Saito |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
279-0021
Address
2-1-1 Tomioka Urayasushi Chibaken Japan
TEL
047-353-3111
anyusaike@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Anneyuko |
| Middle name | Ikeda |
| Last name | Saito |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Radiation Oncology
Zip code
279-0021
Address
2-1-1 Tomioka Urayasushi Chibaken Japan
TEL
047-353-3111
Homepage URL
anyusaike@yahoo.co.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
This work was supported by an intramural grant of the Department of Respiratory Medicine at Juntendo University, Tokyo, Japan
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
IRB of Juntendo Urayasu Hospital
Address
2-1-1 Tomioka Urayasushi Chibaken Japan
Tel
047-353-3111
anyusaike@yahoo.co.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
| 2019 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35715357/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35715357/
Number of participants that the trial has enrolled
19
Results
The group with SUVmax 2.5 or higher on the PET/CT taken more than 2 month after completion of radiotherapy(post-PET/CT) showed high SUVmax on the PET/CT taken within 24 hours of completing radiotherapy(im-PET/CT) (p=0.004). Receiver operator curve analysis indicated that im-PET/CT-SUVmax of 4.35 was an optimal cut-off value to discriminate the two groups.
Multivariable analysis showed that a high im-PET/CT-SUVmax was significantly associated with a high post-PET/CT-SUVmax(p=0.003).
Results date posted
| 2025 | Year | 01 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients were eligible if they had a primary lung cancer diagnosis based on histology; are planned to receive curative-intent CCRT treatment; and provided consent of being discharged on the last day of RT to take im-PET/CT within 24 hours.
Participant flow
To take im-PET/CT and post-PET/CT
Adverse events
none
Outcome measures
SUVmax
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042702
