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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Glioma, Breast Cancer

Intervention / Treatment
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* Radiation: 68Ga-NOTA-NFB


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Volunteers<br>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<br>* 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.<br>|
| Glioma Patients<br>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<br>* 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.<br>|
| Breast Cancer Patients<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUV of organs | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemokine receptor, galium, dosimetry, glioma