UMIN-ICDS Clinical Trial

Public title

Nationwide Analysis of Radioligand Therapy Implementation in Japan: Trends and Barriers Using Claims Data and Questionnaire Survey

Acronym

Nationwide Analysis of Radioligand Therapy Implementation in Japan: Trends and Barriers Using Claims Data and Questionnaire Survey

Scientific Title

Nationwide Analysis of Radioligand Therapy Implementation in Japan: Trends and Barriers Using Claims Data and Questionnaire Survey

Scientific Title:Acronym

Nationwide Analysis of Radioligand Therapy Implementation in Japan: Trends and Barriers Using Claims Data and Questionnaire Survey

Region

Japan

Condition

1) Patients who received treatment with a radiopharmaceutical therapy agent listed on the National Health Insurance (NHI) drug price list in Japan.
Although [(131)I]I is approved in Japan for hyperthyroidism as well as thyroid cancer, this study will include only patients who received [(131)I]I for thyroid cancer.
2) Patients who initiated systemic therapy for a neuroendocrine neoplasm.

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aims of this study are to clarify the implementation status of Radiopharmaceutical therapy (RPT) in Japan and its impact on treatment strategy in clinical practice.

Basic objectives2

Others

Basic objectives -Others

The aims of this study are to identify operational and implementation challenges through a facility survey, thereby characterizing the current status and issues surrounding RPT.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1) RPT component
Temporal trends in the total number of patients newly treated with RPT for malignant tumors.
2) NET component
Temporal trends in the number of patients newly treated with systemic therapy for neuroendocrine neoplasms, including 177Lu-DOTATATE, by treatment type.
3) Cross-sectional facility survey component
Barriers in operating or implementing RPT at medical institutions.

Key secondary outcomes

1) RPT component
1. Temporal trends in the total number of RPT treatments administered
2. Temporal trends in the number of treatments administered and the number of newly treated patients, by therapeutic agent
3. Temporal trends in the total number of RPT treatments administered and the number of newly treated patients, by prefecture
4. Balance of interprefectural inflow and outflow of patients newly treated with RPT.
2) NET component
1. Temporal trends in the number of patients newly treated with 177Lu-DOTATATE, by prefecture
2. Balance of interprefectural inflow and outflow of patients newly treated with 177Lu-DOTATATE.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

For the Radioligand therapy component and the Neuroendocrine tumor Component, data will be extracted from the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) for patients who meet all of the following criteria. For the cross-sectional facility survey component, a questionnaire will be sent to medical institutions to collect information on the challenges they face in operating or implementing RPT.

1) RPT component
1. Patients with at least one claim during the study period (January 2017 to December 2025).
2. Patients who received treatment with an RPT agent listed on the National Health Insurance (NHI) drug price list in Japan.
Although 131I is approved in Japan for hyperthyroidism as well as thyroid cancer, this study will include only patients who received 131I for thyroid cancer.

RPT is listed on the NHI drug price list in Japan as of September 2025:
-Sodium iodide (131I)
-Strontium chloride (89Sr) (Metastron)
-90Y-ibritumomab tiuxetan (Zevalin)
-Radium chloride (223Ra) (Xofigo)
-177Lu-DOTATATE (Lutathera)
-131I-MIBG (3-iodobenzylguanidine 131I; Raiatt MIBG-I131)
If 177Lu-PSMA-617 (Pluvicto) is added to the NHI drug price list by December 2025, its inclusion in this study will be considered.

2) Neuroendocrine tumor component
1. Patients who had at least one medical encounter between January 2017 and December 2025.
2. Patients with a disease name code for a neuroendocrine neoplasm recorded in the NDB.
3. Patients who initiated systemic therapy for a neuroendocrine neoplasm.

3) Cross-sectional facility survey component.
1. Medical institutions participating in JON-HBP.
2. Institutions will be included regardless of whether they currently administer RPT.

Key exclusion criteria

Not applicable

Target sample size

Name of lead principal investigator

1st name	Masafumi
Middle name
Last name	Ikeda

Organization

National Cancer Center Hospital East

Division name

Hepatobiliary and Pancreatic Oncology

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

TEL

+81-4-7133-1111

Email

masikeda@east.ncc.go.jp

Name of contact person

1st name	Hiroshi
Middle name
Last name	Imaoka

Organization

National Cancer Center Hospital East

Division name

Hepatobiliary and Pancreatic Oncology

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa, Chiba

TEL

04-7133-1111

Homepage URL

Email

hiimaoka@east.ncc.go.jp

Institute

National Cancer Center

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center Institutional Review Board

Address

6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

Tel

+81-4-7133-1111

Email

IRBsupport@east.ncc.go.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

2026

Year

10

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2025

Year

12

Month

01

Day

Date of IRB

2025

Year

12

Month

19

Day

Anticipated trial start date

2025

Year

12

Month

01

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The aims of this study is to clarify the implementation status of Radiopharmaceutical (RPT) in Japan and its impact on treatment strategy in clinical practice, and to identify operational and implementation challenges through a facility survey, thereby characterizing the current status and issues surrounding RPT.
0.3 Methods
This study is a nationwide mixed-methods study that combines analyses of health insurance claims data with a facility survey. It aims to characterize the utilization of RPT in cancer care in Japan and to identify operational and implementation barriers. Specifically, it integrates (i) a nationwide assessment, based on claims data, of RPT utilization and of the impact of RPT on treatment strategies in clinical practice, with (ii) a facility survey. Through this integration, the study seeks to provide a more comprehensive picture of current practice. The study consists of the following three components.
1) RPT component
Using the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), we will analyze the utilization of RPT for malignant tumors before and after the approval of 177Lu-DOTATATE. The analysis will cover temporal trends in the total number of treatments administered and the number of newly treated patients, both overall and by therapeutic agent, as well as regional variation.
2) Neuroendocrine tumor component
Using the NDB, we will analyze the use of systemic therapies for neuroendocrine tumor (NET), including 177Lu-DOTATATE, before and after its approval. The analysis will cover temporal trends in the number of newly treated patients by treatment type, as well as regional variation in the use of 177Lu-DOTATATE.
3) Cross-sectional facility survey component
A questionnaire will be sent to institutions participating in the Japan Oncology Network in Hepatobiliary and Pancreas (JON-HBP) to identify operational issues in facilities that administer RPT, as well as barriers to its implementation.

Registered date

2026

Year

10

Month

05

Day

Last modified on

2026

Year

10

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072307