UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020814
Receipt number R000024029
Scientific Title Usefulness of FDG-PET/CT to predict the response after nivolumab in patients with previously treated advanced non-small cell lung cancer
Date of disclosure of the study information 2016/02/01
Last modified on 2016/02/10 20:07:24

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Basic information

Public title

Usefulness of FDG-PET/CT to predict the response after nivolumab in patients with previously treated advanced non-small cell lung cancer

Acronym

FDG-PET/CT and prediction of nivolumab in lung cancer

Scientific Title

Usefulness of FDG-PET/CT to predict the response after nivolumab in patients with previously treated advanced non-small cell lung cancer

Scientific Title:Acronym

FDG-PET/CT and prediction of nivolumab in lung cancer

Region

Japan


Condition

Condition

Previously treated advanced non-small cell lung cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Nivolumab, a programmed death 1 immune checkpoint inhibitor antibody, was effective for patients with previously treated advanced NSCLC. However, the presence of promising biomarker still remains unclear. Little is known about the role of CT scan as an appropriate radiological modality. Therefore, we conducted the clinical study to evaluate FDG-PET as a predictor of nivolumab.

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 novolumab

Evaluation after 1 month from administration of nivolumab

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

Medicine Device,equipment

Interventions/Control_1

All patients undergo FDG-PET/MRI before and 4 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) 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

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kyochi Kaira

Organization

Gunma Univetsity Hospital

Division name

Advanced medicine

Zip code


Address

showa-machi, Mebashi <gunma

TEL

027-220-8136

Email

kkaira1970@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kyoichi Kaira

Organization

Gunma University Hospital

Division name

Advanced medicine

Zip code


Address

showa-machi, Meabasshi, Gunm , Japan

TEL

027-220-8136

Homepage URL


Email

kkaira1970@yahoo.co.jp


Sponsor or person

Institute

Gunma

Institute

Department

Personal name



Funding Source

Organization

Gunma, Department of respiratoru

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


Email



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 02 Month 01 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

Open public recruiting

Date of protocol fixation

2016 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 01 Day

Last modified on

2016 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024029


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name