UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025980 |
|---|---|
| Receipt number | R000029864 |
| Scientific Title | Usefulness of FAMT-PET to predict the response after chemotherapy in patients withmalignant lymphoma |
| Date of disclosure of the study information | 2017/02/03 |
| Last modified on | 2025/08/11 11:42:03 |
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Basic information
Public title
Usefulness of FAMT-PET to predict the response after chemotherapy in patients withmalignant lymphoma
Acronym
FAMT-PET and prediction of chemotherapy in malignant lymphomna
Scientific Title
Usefulness of FAMT-PET to predict the response after chemotherapy in patients withmalignant lymphoma
Scientific Title:Acronym
FAMT-PET and prediction of chemotherapy in malignant lymphomna
Region
| Japan |
Condition
Condition
malignant lymphoma
Classification by specialty
| Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
FDG-PET yields a false positive finding to cancer diagnosis and detection. FAMT-PET is a tumor specific PET , nicely differring malignancy and inflammatory lesions. Therefore, we conducted the clinical study to evaluate FAMT-PET as a predictor of chemotherapy.
Basic objectives2
Others
Basic objectives -Others
To monitor the outcome after treatment
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changeing of SUVmax, MTV and TLG, and the efficacy of chemotherapy
Evaluation after 2 cycles from initial chemotherapy
Key secondary outcomes
Survival and adverse events
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
| Device,equipment |
Interventions/Control_1
All patients undergo FAMT-PET/MRI before and 2 cycles after chemotherapy
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
Male and Female
Key inclusion criteria
1) Pathologically confirmed malignant lymphoma, chemo-naive case.
2) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
3) Patient with evaluable lesion based on RECIST
4) Written informed consent
Key exclusion criteria
1) Pregnant woman
2) Patients with obvious interstitial pneumonia or pulmonary fibrosis in the chest X-ray.
3) Patients with collagen vascular disease or autoimmune diseases
4) Other cases attending physician it is determined unsuitable for registration of the study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norifumi Tsukamoto |
Organization
Gunma Univetsity Hospital
Division name
Oncology Center
Zip code
Address
3-39-15, showa-machi, Maebashi, Gunma
TEL
027-220-8529
tsukamoto@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma Univetsity Hospital
Division name
Oncology Clinical Development
Zip code
Address
3-39-15, showa-machi, Maebashi, Gunma
TEL
027-220-8222
Homepage URL
kkaira1970@yahoo.co.jp
Sponsor or person
Institute
Gunma Univetsity
Institute
Department
Personal name
Funding Source
Organization
Gunma Univetsity
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
Address
Tel
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
| 2017 | Year | 02 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 03 | Day |
Last modified on
| 2025 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029864
