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

Safety and Diagnostic Performance of 68Gallium-labeled NOTA-BBN-RGD PET/CT in Prostate Cancer Patients

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02747290

Enrollment

Registered

2016-04-21

Start date

2014-07-31

Completion date

Unknown

Last updated

2016-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

BBN-RGD, PET, integrin αvβ3, GRPR

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-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

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.

Interventions

DRUG68Ga-NOTA-BBN-RGD

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Standardized uptake value of 68Ga-NOTA-BBN-RGD in prostate cancer	1 year	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

Measure	Time frame	Description
Adverse events collection	1 week	Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.

Countries

China

Contacts

Primary ContactZhaohui Zhu, MD.PhD.

13611093752@163.com+86 10 69154196

Backup ContactJingjing Zhang, MD.PhD.

zhangjingjingtag@163.com+86 10 69155513

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026