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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02747290
• Other study ID #: PUMCHNM011
• Secondary ID: ZIAEB000073
• Status: Recruiting
• Phase: Phase 0
• First received: April 19, 2016
• Last updated: April 19, 2016
• Start date: July 2014

Study information

• Verified date: March 2016
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, MD.PhD.
• Phone: +86 10 69154196
• Email: 13611093752[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value of 68Ga-NOTA-BBN-RGD in prostate cancer	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.	1 year	No
Secondary	Adverse events collection	Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.	1 week	Yes