NCT03546478

Brief Summary

This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the diagnostic performance and evaluation efficacy of 99mTc-ABH2 in breast cancer patients. A single dose of 370±54 Mega-Becquerel (MBq)99mTc-ABH2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for early_phase_1 breast-cancer

Timeline
Completed

Started Jun 2015

Typical duration for early_phase_1 breast-cancer

Geographic Reach
1 country

1 active site

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

June 24, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
Last Updated

June 6, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

May 23, 2018

Last Update Submit

June 4, 2018

Conditions

Breast Cancer

Keywords

SPECT/CTHER2 imaging

Outcome Measures

Primary Outcomes (1)

  • T/B

    Target/Background ratio of 99mTc-ABH2 SPECT/CT in Diagnosis of HER2-positive breast cancer

    1 year

Secondary Outcomes (1)

  • Adverse events collection

    1 week

Study Arms (1)

99mTc-ABH2 SPECT/CT

EXPERIMENTAL

The patients were injected with 370±54 MBq of 99mTc-ABH2 in one dose intravenously and underwent SPECT/CT scan 90-270 min later.

Biological: 99mTc-ABH2

Interventions

99mTc-ABH2BIOLOGICAL

99mTc-ABH2 were injected into the patients before the SPECT/CT scans

Also known as: 99mTc labelled HER2 affibody
99mTc-ABH2 SPECT/CT

Eligibility Criteria

Age29 Years - 76 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with breast cancer before surgery Conventional imaging within 1 month Signed written consent Age above 29 years Female

You may not qualify if:

  • Pregnancy Breastfeeding Renal function: serum creatinine \> 3.0 mg/dl Known allergy against affibody Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fang Li, MD

    Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical Colleg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 6, 2018

Study Start

June 24, 2015

Primary Completion

May 24, 2017

Study Completion

May 18, 2018

Last Updated

June 6, 2018

Record last verified: 2018-05

Locations

CN(1)