68Ga-NOTA-NFB: Radiation Dosimetry in Healthy Volunteers and Applications in Glioma Patients or Breast Cancer Patients (GNNGB)

December 29, 2014 updated by: Xijing Hospital

Prospective Imaging Study of 68Ga-NOTA-NFB in Tumors

The purpose of this study is to assess the safety, biodistribution, dosimetric properties of the positron emission tomography (PET) radiopharmaceutical agent 68Ga-NOTA-NFB. To preliminarily evaluate its application in glioma diagnosis.

To assess the application of 68Ga-NOTA-NFB PET/CT in the evaluation of the neoadjuvant chemotherapy in patients with breast cancer before and after the therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

6 healthy volunteers with whole-body PET/CT scans 0, 0.5, 1.0, 2.0, and 3.0 hours after tracer injection (mean dose, 4.93 ± 0.10 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.

8-10 patients with glioma will be enrolled for the clinical study of diagnosing glioma, they will be performed with both 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before surgery. The preoperative images are compared and correlated with the pathologically report. Next, the expression of CXCR4 will be determined by immunohistochemical staining of the resected brain tumor tissues.

30 patients with breast cancer will be underwent 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before and after the neoadjuvant chemotherapy. SUV of lesions before and after therapy will be contrasted.

Study Type

Observational

Enrollment (Anticipated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital Nuclear Medicine Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

6 healthy volunteers. 10 patients with glioma before surgery. 30 patients with breast cancer before and after neoadjuvant chemotherapy.

Description

Inclusion Criteria:

  • volunteers : healthy patients with glioma: diagnosed by MR and ready for surgery patients with breast: cancer appropritate of neoadjuvant chemotherapy.

Exclusion Criteria:

  • patients with glioma: refuse or cannot endure surgery. patients with breast: refuse neoadjuvant chemotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Volunteers
Healthy Volunteers undergo whole-body 68Ga-NOTA-NFB PET/CT scans 0, 0.5, 1.0, 2.0, and 3.0 hours after tracer injection. During the imaging period, 1 mL blood samples are obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-activity curve calculations.
Radiation: 68Ga-NOTA-NFB
In this investigation, 68Ga-NOTA-NFB is employed to a preclinical trial, including radiation dosimetry study in healthy volunteers and the first application in glioma patients, to assess the safety, dosimetry property and evaluate the CXCR4 expression in glioma patients and breast cancer patients.
Glioma Patients
Glioma Patients enrolled for the clinical study of diagnosing glioma are performed with both 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before surgery.
Radiation: 68Ga-NOTA-NFB
In this investigation, 68Ga-NOTA-NFB is employed to a preclinical trial, including radiation dosimetry study in healthy volunteers and the first application in glioma patients, to assess the safety, dosimetry property and evaluate the CXCR4 expression in glioma patients and breast cancer patients.
Breast Cancer Patients
68Ga-NOTA-NFB PET/CT and 18F-FDG PET/CT scans will undergo in patients with breast cancer before and after neoadjuvant chemotherapy.
Radiation: 68Ga-NOTA-NFB
In this investigation, 68Ga-NOTA-NFB is employed to a preclinical trial, including radiation dosimetry study in healthy volunteers and the first application in glioma patients, to assess the safety, dosimetry property and evaluate the CXCR4 expression in glioma patients and breast cancer patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUV of organs
Time Frame: 0, 0.5, 1.0, 2.0, and 3.0hours after injection
The standardized uptake values (SUV) in deferent organs are calculated.
0, 0.5, 1.0, 2.0, and 3.0hours after injection
radioactivity of blood sample
Time Frame: 1, 3, 5, 10, 30,60, 90, 120, 150, and 180minutes
blood samples are obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-radioactivity curve calculations.
1, 3, 5, 10, 30,60, 90, 120, 150, and 180minutes
SUV of glioma
Time Frame: 1 hour after injection
The maximum standardized uptake values (SUVmax) and the maximum target to non-target ratios (T/NTmax) of 68Ga-NOTA-NFB and 18F-FDG in glioma tissues.
1 hour after injection
SUV of Breast Cancer
Time Frame: 1 hour after injection
The maximum standardized uptake values (SUVmax) of 68Ga-NOTA-NFB and 18F-FDG in breast cancer before and after neoadjuvant chemotherapy.
1 hour after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Director: Jing Wang, Doctor, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

December 29, 2014

First Posted (Estimate)

December 30, 2014

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20140522-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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