68Ga-NOTA-BBN-RGD PET/CT in Prostate Cancer Patients

NCT ID: NCT02747290

Last Updated: 2016-04-21

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

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

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-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.

Detailed Description

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Both GRPR and integrin αvβ3 are overexpressed in neoplastic cells of human prostate cancer. To target both receptors, a heterodimeric peptide BBN-RGD was synthesized from bombesin(7-14) and c(RGDyK) through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-BBN-RGD and diagnostic performance of 68Ga-NOTA-BBN-RGD PET/CT in patients with primary and/or metastasis 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-BBN-RGD PET/CT

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.

Group Type EXPERIMENTAL

68Ga-NOTA-BBN-RGD

Intervention Type DRUG

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

Interventions

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68Ga-NOTA-BBN-RGD

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

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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Fang Li, MD.

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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Zhaohui Zhu, MD.PhD.

Role: CONTACT

+86 10 69154196

Jingjing Zhang, MD.PhD.

Role: CONTACT

+86 10 69155513

Facility Contacts

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Jingjing Zhang, MD.

Role: primary

+86 10 69155513

Other Identifiers

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ZIAEB000073

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PUMCHNM011

Identifier Type: -

Identifier Source: org_study_id

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