NCT04906070

Brief Summary

An intratumoral alpha particle based approach for cancer treatment using diffusion alpha-emitting radiation therapy (DaRT)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started May 2019

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2022

Completed
Last Updated

June 3, 2022

Status Verified

June 1, 2022

Enrollment Period

2.9 years

First QC Date

May 25, 2021

Last Update Submit

June 2, 2022

Conditions

Breast CancerHead and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor response to HB-001

    Assessment of tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

    9 - 11 weeks after HB-001 seed insertion

Secondary Outcomes (1)

  • Adverse Events

    12 weeks after HB-001 insertion

Study Arms (1)

HB-001 DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: HB-001

Interventions

HB-001DEVICE

An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.

Also known as: DaRT(Diffusing Alpha Radiation Emitters Therapy)
HB-001 DaRT Seeds

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Head and neck cancer or breast cancer patients with histopathological proven malignancies who have a history of radiation therapy and who have been diagnosed with refractory malignancies with or without medical treatment.
  • Tumor size is 5 cm or less in the longest diameter
  • Age 18 years or older
  • Eastern Cooperative Oncology Group performance status is 2 or less
  • Life expectancy: 6 months or longer
  • Vital signs (systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate) are stable
  • Platelet count \>= 100,000/mm3 and prothrombin time Prothrombin Time-International Normalized Ratio \<= 1.8
  • Women of childbearing potential have to be confirmed not pregnant by a pregnancy test and have to agree to prevent conception throughout the study.
  • Having received explanation about the study, consented to participate in the study and signed the informed consent form.
  • Measurable disease according to RECIST v1.1

You may not qualify if:

  • The size of the tumor more than 5 cm in the maximum diameter.
  • ECOG performance status is 3 or higher
  • Continuously receiving medication that may have a significant impact on the evaluation of safety or efficacy, such as immunosuppressants and/or corticosteroids.
  • History of serious allergy to the medicine for the treatments like anesthesia.
  • There are tumors to be preferentially treated such as metastatic lesion other than the target tumor
  • Having received chemotherapeutic drugs (except hormonal agents), immunotherapeutic agents, and molecular targeting agents in the past 30 days, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy.
  • Having received immune checkpoint inhibitor in the past 2 months, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy.
  • Having participated in different clinical studies in the past 30 days, which may affect the assessment of the safety or efficacy of HB-001 brachytherapy
  • Pregnant women or breast-feeding mothers
  • Those who do not wish to sign the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Tohoku University Hospital

Miyagi, 980-8574, Japan

Location

Kansai Medical University Hospital

Osaka, 573-1191, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

Tokyo Medical And Dental University Medical Hospital

Tokyo, 113-8519, Japan

Location

MeSH Terms

Conditions

Breast NeoplasmsHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Toshiro Mabuchi

    Hekabio

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2021

First Posted

May 28, 2021

Study Start

May 25, 2019

Primary Completion

March 31, 2022

Study Completion

May 27, 2022

Last Updated

June 3, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

JP(4)