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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown
Early Phase 1

Conditions

Prostate Cancer

Treatments

Drug: 68Ga-NOTA-BBN-RGD

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02747290
PUMCHNM011
ZIAEB000073 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 estimated patients

Sex

Male

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

68Ga-NOTA-BBN-RGD PET/CT
Experimental group
Description:
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.
Treatment:
Drug: 68Ga-NOTA-BBN-RGD

Trial contacts and locations

1

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Central trial contact

Zhaohui Zhu, MD.PhD.; Jingjing Zhang, MD.PhD.

Data sourced from clinicaltrials.gov

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