NCT02749019

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-BBN-RGD in breast cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

April 20, 2016

Last Update Submit

April 21, 2016

Conditions

Breast Cancer

Keywords

BBN-RGDGRPRintegrin αvβ3

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value of 68Ga-NOTA-BBN-RGD in breast cancer

    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 cancer will be measured.

    1 year

Study Arms (1)

68Ga-NOTA-BBN-RGD PET/CT

EXPERIMENTAL

The patients were injected with 111-148 MBq of 68Ga-NOTA-BBN-RGD in one dose intravenously and underwent PET/CT scan 15-30 min later.

Drug: 68Ga-NOTA-BBN-RGD

Interventions

68Ga-NOTA-BBN-RGDDRUG

68Ga-NOTA-BBN-RGD were injected into the patients before the PET/CT scans

68Ga-NOTA-BBN-RGD PET/CT

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neoplasm identified by X-ray, ultrasound or MRI as breast cancer
  • To provide basic information and sign the written informed consent.

You may not qualify if:

  • Consisted of conditions of mental illness;
  • Severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
  • Severe allergy or hypersensitivity to IV radiographic contrast
  • Claustrophobia to accept the PET/CT scanning
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Zhaohui Zhu, MD. PhD.

CONTACT

+86 10 69154196zhuzhh@pumch.cn

Jingjing Zhang, MD. PhD

CONTACT

+86 10 69155513zhangjingjing@pumch.cn

Study Design

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

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 22, 2016

Study Start

July 1, 2015

Primary Completion

July 1, 2018

Last Updated

April 22, 2016

Record last verified: 2016-04

Locations

CN(1)