NCT06194565

Brief Summary

This prospective study will investigate the potential usefulness of 99mTc-ABH2 SPECT/CT in the diagnostic performance and evaluation efficacy of breast cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

March 20, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

January 8, 2024

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

December 22, 2023

Last Update Submit

December 22, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • SPECT/CT-based 99mTc-ABH2 uptake value in tumor lesions

    Uptake of 99mTc-ABH2 in the lesions will be assessed using SPECT/CT and measured in standardized uptake value (SUV).

    1 year

Study Arms (1)

99mTc-ABH2 SPECT/CT

EXPERIMENTAL

The patients will be injected with 5.55 to 7.4 MBq per kilogram body weight of 99mTc-ABH2 in one dose intravenously and undergo SPECT/CT scan 1h to 2h later.

Drug: 99mTc-ABH2

Interventions

99mTc-ABH2DRUG

Each patient will receive an intravenous injection of 99mTc-ABH2, and undergo a SPECT/CT scan within specified time.

99mTc-ABH2 SPECT/CT

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinically suspected primary breast cancer by mammography or ultrasonography and being able to sign the written informed consent form

You may not qualify if:

  • pregnancy or lactation, impaired liver or kidney failure, and undergoing any preceding local or systemic therapies that might interfere HER2 binding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hongli MD Jing

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuwei Zhang

CONTACT

+8618511071577ywzhangwork@163.com

Hongli MD Jing

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 8, 2024

Study Start

March 20, 2023

Primary Completion

December 30, 2023

Study Completion

January 30, 2024

Last Updated

January 8, 2024

Record last verified: 2023-12

Locations

CN(1)