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

Early Phase 1

• Conditions: Prostate Cancer
• Interventions: Drug: 68Ga-NOTA-BBN-RGD

• Registration Number: NCT02747290
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2014-07
• Status Verified: 2016-03
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-19
• Last Update Submitted: 2016-04-19
• Study First Posted: 2016-04-21
• Last Update Posted: 2016-04-21
• Primary Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NOTA-BBN-RGD PET/CT	68Ga-NOTA-BBN-RGD	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China