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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-NOTA-Aca-BBN(7-14) 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.

Group Type EXPERIMENTAL

68Ga-NOTA-Aca-BBN

Intervention Type DRUG

68Ga-NOTA-Aca-BBN(7-14) were injected into the patients before the PET/CT scans

PET/CT

Intervention Type DEVICE

Interventions

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68Ga-NOTA-Aca-BBN

68Ga-NOTA-Aca-BBN(7-14) were injected into the patients before the PET/CT scans

Intervention Type DRUG

PET/CT

Intervention Type DEVICE

Other Intervention Names

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68Ga-NOTA-Aca-BBN(7-14)

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes