68Ga-NOTA-NFB: Radiation Dosimetry in Healthy Volunteers and Applications in Glioma Patients or Breast Cancer Patients
- Conditions
- Breast CancerGlioma
- Interventions
- Radiation: 68Ga-NOTA-NFB
- Registration Number
- NCT02327442
- Lead Sponsor
- Xijing Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 46
- volunteers : healthy patients with glioma: diagnosed by MR and ready for surgery patients with breast: cancer appropritate of neoadjuvant chemotherapy.
- patients with glioma: refuse or cannot endure surgery. patients with breast: refuse neoadjuvant chemotherapy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Glioma Patients 68Ga-NOTA-NFB 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. Volunteers 68Ga-NOTA-NFB 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. Breast Cancer Patients 68Ga-NOTA-NFB 68Ga-NOTA-NFB PET/CT and 18F-FDG PET/CT scans will undergo in patients with breast cancer before and after neoadjuvant chemotherapy.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Xijing Hospital Nuclear Medicine Department
🇨🇳Xi'an, Shaanxi, China