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

NCT ID: NCT03164837

Last Updated: 2017-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-11-30

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-NOTA-RM26 PET/CT

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.

Group Type EXPERIMENTAL

68Ga-NOTA-RM26

Intervention Type DRUG

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

Interventions

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68Ga-NOTA-RM26

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhaohui Zhu, M.D.,PhD.

Role: STUDY_CHAIR

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

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jingjing Zhang, M.D.,PhD.

Role: CONTACT

+86 10 69154196

Facility Contacts

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Jingjing Zhang, M.D.,PhD.

Role: primary

Other Identifiers

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ZIAEB000073

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PekingUMCH-NM021

Identifier Type: -

Identifier Source: org_study_id

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