Breast Cancer, Glioma
Conditions
Keywords
chemokine receptor, galium, dosimetry, glioma
Brief summary
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
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.
Interventions
RADIATION68Ga-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.
Sponsors
Xijing Hospital
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SUV of organs | 0, 0.5, 1.0, 2.0, and 3.0hours after injection | The standardized uptake values (SUV) in deferent organs are calculated. |
| radioactivity of blood sample | 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. |
| SUV of glioma | 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. |
| SUV of Breast Cancer | 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. |
Countries
China
Contacts
Primary ContactJing Wang, Doctor
Backup ContactZhe Wang, Doctor
Outcome results
None listed