68Ga-NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas

Early Phase 1

• Conditions: Glioma
• Interventions: Drug: 68Ga-NOTA-Aca-BBN; Device: PET/CT

• Registration Number: NCT02520882
• 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-Aca-BBN(7-14) in glioma patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-Aca-BBN(7-14) will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Detailed Description

Non-invasive imaging evaluation of GRPR expression would be of great help in drug development, patient stratification and therapeutic response monitoring. Various GRPR targeting imaging probes have been develop to meet the purpose. Bombesin (BBN) is an amphibian homolog of mammalian gastrin-releasing peptide (GRP). 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 gastrin-releasing peptide receptor (GRPR), after being labeled with various radionuclides. Multiple preclinical studies have demonstrated receptor-specific accumulation of the tracers in GRPR positive tumors. For interests in clinical translation of 68Ga-NOTA-Aca-BBN(7-14), an open-label dynamic whole-body PET/ CT study was designed to investigate the safety and diagnostic performance of 68Ga-NOTA-Aca-BBN(7-14) in patients with glioma.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-03
• Study First Submitted: 2015-08-02
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

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

Inclusion Criteria

• Must be able to provide a written informed consent
• Clinically based and magnetic resonance imaging (MRI)-based suspected newly diagnosed primary glioma.
• The tumor will be surgically removed and histological diagnosis will be available.

Exclusion Criteria

• Females planning to bear a child recently or with childbearing potential；
• Known severe allergy or hypersensitivity to IV radiographic contrast；
• Inability to lie still for the entire imaging time because of cough, pain, etc.
• Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
• Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NOTA-Aca-BBN(7-14) PET/CT	68Ga-NOTA-Aca-BBN	The patients were injected with 111-148 MBq of 68Ga-NOTA-Aca-BBN(7-14) in one dose intravenously and underwent PET/CT scan 30 min later.
68Ga-NOTA-Aca-BBN(7-14) PET/CT	PET/CT	The patients were injected with 111-148 MBq of 68Ga-NOTA-Aca-BBN(7-14) in one dose intravenously and underwent PET/CT scan 30 min later.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value of 68Ga-NOTA-Aca-BBN(7-14) in primary glioma	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 primary glioma 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