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68Ga-NOTA-RM26 PET/CT in Prostate Cancer Patients

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-NOTA-RM26
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-NOTA-RM26 PET/CT

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse events collection
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed

Full Information

First Posted
May 23, 2017
Last Updated
May 23, 2017
Sponsor
Peking Union Medical College Hospital
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
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1. Study Identification

Unique Protocol Identification Number
NCT03164837
Brief Title
68Ga-NOTA-RM26 PET/CT in Prostate Cancer Patients
Official Title
Safety and Diagnostic Performance of 68Gallium-labeled NOTA-RM26 PET/CT in Prostate Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including prostate cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human prostate cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-RM26 and to assess its clinical diagnostic value in patients with prostate cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-NOTA-RM26 PET/CT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
68Ga-NOTA-RM26
Intervention Description
Single-dose 68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans.
Primary Outcome Measure Information:
Title
Standardized uptake value of 68Ga-NOTA-RM26 in prostate cancer
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events collection
Description
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingjing Zhang, M.D.,PhD.
Phone
+86 10 69154196
Email
zhangjingjingtag@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, M.D.,PhD.
Organizational Affiliation
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingjing Zhang, M.D.,PhD.
Email
zhangjingjingtag@163.com
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, M.D.,PhD.

12. IPD Sharing Statement

Learn more about this trial

68Ga-NOTA-RM26 PET/CT in Prostate Cancer Patients

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