NCT03347864

Brief Summary

This is an open-label positron emission tomography/computed tomography(PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in breast tumor patients. 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26A will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

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
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2016

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

October 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

November 16, 2017

Last Update Submit

November 16, 2017

Conditions

Breast Tumor

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value of 68Ga-NOTA-RM26 in breast tumor

    The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured.

    1 year

Secondary Outcomes (1)

  • Adverse events collection

    1 week

Study Arms (1)

68Ga-NOTA-RM26 PET/CT

EXPERIMENTAL

The patients were injected with 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 in one dose intravenously and underwent PET/CT scan 30-45 min later

Drug: 68Ga-NOTA-RM26

Interventions

68Ga-NOTA-RM26DRUG

1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans

68Ga-NOTA-RM26 PET/CT

Eligibility Criteria

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

You may qualify if:

  • patients in suspicion of breast cancer by mammography or ultrasonography,and being able to provide basic information and sign the written informed consent form

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

Interventions

68Ga-NOTA-RM26

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Zhaohui Zhu, MD,PHD

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

    STUDY CHAIR

Central Study Contacts

Jie Zang, MD

CONTACT

+86 10 6915419615901495106@163.com

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

November 16, 2017

First Posted

November 20, 2017

Study Start

October 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

CN(1)