NCT03164837

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 prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-RM26 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 phase_1 prostate-cancer

Timeline
Completed

Started Nov 2016

Shorter than P25 for 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

November 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

May 23, 2017

Last Update Submit

May 23, 2017

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value of 68Ga-NOTA-RM26 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-RM26 PET/CT

EXPERIMENTAL

The patients were injected with 111-148 MBq of 68Ga-NOTA-RM26 in one dose intravenously and underwent PET/CT scan 15-30 min later.

Drug: 68Ga-NOTA-RM26

Interventions

68Ga-NOTA-RM26DRUG

Single-dose 68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans.

68Ga-NOTA-RM26 PET/CT

Eligibility Criteria

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

You may qualify if:

  • Patients with diagnosis of primary prostate cancer having a prostate neoplasm identified by ultrasound or MRI, being diagnosed by needle biopsy as having prostate cancer, having undergone whole-body bone scanning, 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

Prostatic Neoplasms

Interventions

68Ga-NOTA-RM26

Condition Hierarchy (Ancestors)

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

Study Officials

  • Zhaohui Zhu, M.D.,PhD.

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

    STUDY CHAIR

Central Study Contacts

Jingjing Zhang, M.D.,PhD.

CONTACT

+86 10 69154196zhangjingjingtag@163.com

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

May 23, 2017

First Posted

May 24, 2017

Study Start

November 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

May 24, 2017

Record last verified: 2017-05

Locations

CN(1)