NCT02747290

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 prostate 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
30

participants targeted

Target at P75+ for early_phase_1 prostate-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

July 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

April 21, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

April 19, 2016

Last Update Submit

April 19, 2016

Conditions

Prostate Cancer

Keywords

BBN-RGDPETintegrin αvβ3GRPR

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value of 68Ga-NOTA-BBN-RGD in prostate 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 prostate cancer will be measured.

    1 year

Secondary Outcomes (1)

  • Adverse events collection

    1 week

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 - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be able to provide a written informed consent, needle biopsy diagnosed as prostate cancer, have undergone whole body bone scan, able to provide basic information and sign the written informed consent.

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

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Fang Li, MD.

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

    STUDY CHAIR

Central Study Contacts

Zhaohui Zhu, MD.PhD.

CONTACT

+86 10 6915419613611093752@163.com

Jingjing Zhang, MD.PhD.

CONTACT

+86 10 69155513zhangjingjingtag@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

April 19, 2016

First Posted

April 21, 2016

Study Start

July 1, 2014

Primary Completion

July 1, 2017

Last Updated

April 21, 2016

Record last verified: 2016-03

Locations

CN(1)