UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020707
Receipt number R000023415
Scientific Title FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer
Date of disclosure of the study information 2016/01/23
Last modified on 2020/06/03 11:01:21

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Basic information

Public title

FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer

Acronym

FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer

Scientific Title

FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer

Scientific Title:Acronym

FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer

Region

Japan


Condition

Condition

Previously treated non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Nivolumab, a programmed death 1 immune checkpoint inhibitor antibody, was active and durable in some patients with advanced non-small cell lung cancer. However, it is difficult to evaluate early response with conventional imaging (i.e. computed tomography).
The aim of this study is to clarify whether serial change of FDG-PET/MRI findings can predict long term tumor response of nivolumab monotherapy.

Basic objectives2

Others

Basic objectives -Others

To evaluate diagnostic relevancy of FDG-PET/MRI imaging.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Relationship between serial FDG-PET/MRI findings and progression free survival and tumor response.

Key secondary outcomes

1. Association of serial change of FDG-PET/MRI findings with overall survival.
2. To evaluate the FDG-PET/MRI findings of side effect of nivolumab therapy.
3. Association of FDG-PET/MRI findings and PD-L1 expression of lung cancer.


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 FDG-PET/MRI before and 2, 8 and 16 weeks after initiation of nivolumab therapy.

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 advanced non-small cell lung cancer (NSCLC), and one or more prior systemic treatment regimens for advanced NSCLC
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) Fasting serum glucose levels above 150 mg/dl
2) Pregnant woman
3) Patients with metalic device in their body
4) Patients with claustrophobia
5) Patients with obvious interstitial pneumonia or pulmonary fibrosis in the chest X-ray.
6) Patients with collagen vascular disease or autoimmune diseases
7) Other cases attending physician it is determined unsuitable for registration of the study

Target sample size

25


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 or person

Institute

Third department of internal medicine, Universtiy of Fukui

Institute

Department

Personal name



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

2016 Year 01 Month 23 Day


Related information

URL releasing protocol

https://jitc.bmj.com/content/8/1/e000349

Publication of results

Unpublished


Result

URL related to results and publications

https://jitc.bmj.com/content/8/1/e000349

Number of participants that the trial has enrolled

25

Results

Patients with non-progressive disease (non-PD) had significantly decreased TLG, increased ADCmean (that is, negative dADCmean), and lower dTLG+dADCmean than patients with PD. Among the parameters tested, receiver operating characteristic curve analysis revealed that a cut-off value of 16.5 for dTLG+dADCmean had the highest accuracy (92%) for distinguishing between non-PD and PD patients.

Results date posted

2020 Year 06 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Twenty-five patients with previously treated NSCLC were enrolled prospectively and underwent 18F-FDG PET/MRI before and at 2 weeks after nivolumab therapy.

Participant flow

We prospectively enrolled 25 consecutive patients treated at the University of Fukui Hospital from January 2016 to February 2018, and the protocol-defined final analysis was performed on August 31, 2018.

Adverse events

None

Outcome measures

A cut-off value of 16.5 for dTLG+dADCmean had the highest accuracy (92%) for distinguishing between non-PD and PD patients

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 01 Month 18 Day

Date of IRB

2016 Year 01 Month 22 Day

Anticipated trial start date

2016 Year 01 Month 23 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 01 Month 23 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=R000023415


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name