Dual Integrin αvβ3 and GRPR Targeting PET Imaging in Breast Cancer Patients

NCT ID: NCT02749019

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31

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 breast 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

Gastrin-releasing peptide receptor (GRPR) is a member of the G protein-coupled receptor family of bombesin receptors, which is over-expressed in various types of cancer cells, including prostate cancer, breast cancer, colorectal cancer, pancreatic cancer, glioma, lung cancer, ovarian cancers, endometrial cancers, renal cell cancer and gastrointestinal stromal tumors. BBN(7-14), with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of GRPR. On the other hand, the RGD moiety binds with integrin αvβ3 receptor, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human breast 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 breast cancer patients.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

68Ga-NOTA-BBN-RGD

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Neoplasm identified by X-ray, ultrasound or MRI as breast cancer
• To provide basic information and sign the written informed consent.

Exclusion Criteria

• Consisted of conditions of mental illness;
• Severe liver or kidney disease with serum creatinine > 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
• Severe allergy or hypersensitivity to IV radiographic contrast
• Claustrophobia to accept the PET/CT scanning
• Pregnancy or breast feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhaohui Zhu, MD. PhD.

Role: CONTACT

zhuzhh@pumch.cn

+86 10 69154196

Jingjing Zhang, MD. PhD

Role: CONTACT

zhangjingjing@pumch.cn

+86 10 69155513

Facility Contacts

Zhaohui Zhu, MD. PhD.

Role: primary

zhuzhh@pumch.cn

+86 10 69154196

Other Identifiers

ZIAEB000073

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PUMCHNM012

Identifier Type: -

Identifier Source: org_study_id