UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000027540
Receipt No. R000031462
Scientific Title Analysis of FLT-PET imaging as a predictor of hematologic toxicity of chemotherapy in patients with lung cancer
Date of disclosure of the study information 2017/05/31
Last modified on 2020/06/03 (Ver. 6)

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Basic information
Public title Analysis of FLT-PET imaging as a predictor of hematologic toxicity of chemotherapy in patients with lung cancer
Acronym FLT-PET imaging as a predictor of hematologic toxicity
Scientific Title Analysis of FLT-PET imaging as a predictor of hematologic toxicity of chemotherapy in patients with lung cancer
Scientific Title:Acronym FLT-PET imaging as a predictor of hematologic toxicity
Region
Japan

Condition
Condition Primary lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Tools are lacking to assess the individual risk of severe hematologic toxicity from chemotherapy.
This study is performed to clarify the prognostic value of FLT-PET imaging for severe hematologic toxicity in patients who recieve systemic chemotherapy for advanced lung cancer.
Basic objectives2 Others
Basic objectives -Others To evaluate diagnostic relevancy of FLT-PET/MRI imaging.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between FLT uptake of the vertebral body and severe hematologic toxities during platinum doublet chemotherapy.
Key secondary outcomes 1, Relationship between FLT uptake of the vertebral body and severe non-hematologic toxities during platinum doublet chemotherapy.
2, Relationship between FLT uptake of the vertebral body and progression-free survival and overall survival.

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 All patients undergo FLT-PET/MRI before initiation of systemic 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) Patients with previously untreated advanced lung cancer
2) Patients who have indication of platinum-based doublet chemotherapy
3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
4) Written informed consent
Key exclusion criteria 1) Pregnant woman
2) Patients with metalic device in their body
3) Patients with claustrophobia
4) Other cases attending physician it is determined unsuitable for registration of the study
Target sample size 55

Research contact person
Name of lead principal investigator
1st name Yukihiro
Middle name
Last name Umeda
Organization University of Fukui
Division name Third department of internal medicine
Zip code 9101193
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL 0776-61-3111
Email umeda@u-fukui.ac.jp

Public contact
Name of contact person
1st name Yukihiro
Middle name
Last name Umeda
Organization University of Fukui
Division name Third department of internal medicine
Zip code 9101193
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL 0776-61-3111
Homepage URL
Email umeda@u-fukui.ac.jp

Sponsor
Institute Third department of internal medicine, Universtiy of Fukui
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 The Research Ethics Committee of University of Fukui
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
Tel 0776-61-3111
Email chiken@ml.cii.u-fukui.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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 31 Day

Related information
URL releasing protocol https://link.springer.com/article/10.1007/s00330-019-06161-4
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s00330-019-06161-4
Number of participants that the trial has enrolled 50
Results 
Severe hematological toxicity (HT) (grade3/4) was observed in 40.0% of patients during the first cycle. The ROC curve analyses revealed that the TVP/BSA of L4 was the most discriminative parameter among PET parameters for the prediction of severe HT. Furthermore, the sensitivity, specificity, and accuracy of the TVP/BSA of L4 cut-off of 68.7 to predict grade 3/4 HT were 80.0%, 86.7%, and 84.0%, respectively.
Results date posted
2020 Year 06 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
In this study, 50 patients (median age, 67.5) with newly diagnosed primary lung cancer underwent a pretreatment 18F-FLT PET scan. While 38 patients had non-small cell carcinoma, 12 had small cell carcinoma. We included 8 patients with stage IIA-IIIA in this study because they were judged as a contraindication of surgery or radiotherapy by the attending physician owing to the low pulmonary function. Furthermore, 6 patients had the ECOG-PS of 2.
Participant flow 
Of 75 patients who underwent 18F-FLT PET scan, we subsequently excluded 6 because of the final diagnosis of benign lung diseases and 19 because they received treatments other than platinum-doublet chemotherapy (operation, molecular-targeted drugs, chemoradiotherapy, and single-agent chemotherapy). Thus, we enrolled 50 patients with newly diagnosed primary lung cancer in this study.
Adverse events 
Not applicable
Outcome measures 
Severe hematological toxicity (HT) (grade3/4) was observed in 40.0% of patients during the first cycle. The ROC curve analyses revealed that the TVP/BSA of L4 was the most discriminative parameter among PET parameters for the prediction of severe HT. The multivariate logistic regression analysis revealed the TVP/BSA of L4 (odds ratio [OR], 0.94; P = 0.0036) and the frequency of the grade 3/4 hematological toxicity in previous clinical trials (OR, 1.03; P = 0.023) were independent predictors. Furthermore, the sensitivity, specificity, and accuracy of the TVP/BSA of L4 cut-off of 68.7 to predict grade 3/4 HT were 80.0%, 86.7%, and 84.0%, respectively. A low TVP/BSA of L4 (<68.7) as a binary variable was a significant indicator of severe HT (OR, 26.0; P = 0.000026).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 06 Month 01 Day
Date of IRB
2017 Year 05 Month 22 Day
Anticipated trial start date
2010 Year 06 Month 24 Day
Last follow-up date
2018 Year 02 Month 27 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 05 Month 30 Day
Last modified on
2020 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031462