UMIN-CTR Clinical Trial

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

Primary lung cancer

Classification by specialty

Pneumology	Hematology and clinical oncology	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Third department of internal medicine, Universtiy of Fukui

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

05

Month

31

Day

URL releasing protocol

https://link.springer.com/article/10.1007/s00330-019-06161-4

Publication of results

Published

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

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 related information

Registered date

2017

Year

05

Month

30

Day

Last modified on

2020

Year

06

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031462