Glioma, PARKINSON DISEASE (Disorder), Prostatic Neoplasms
Conditions
Brief summary
This is a study using a parallel control approach and is expected to recruit 35 volunteers, including 8 prostate cancer patients, 8 neuroendocrine tumour patients, 8 glioma patients, 8 Parkinson's syndrome patients, and 3 normal volunteers, to undergo dual-nuclide PET/CT imaging and to validate the isolation effect and quantitative accuracy of simultaneous dual-nuclide imaging in humans.
Interventions
DIAGNOSTIC_TESTPET/CT
Scanning time: acquisition starts 60±10 minutes after 68Ga/18F probe injection; 10-20 minutes after 11C-MET injection; 60 minutes after 11C-CFT injection; Scanning parameters: whole-body imaging (cranial vault to mid-thigh), routine single-nuclide 3 min/bed; dual-nuclide 5-10 min/bed.
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18 \ 75 years old (including boundary values); Gender: male or female; Normal volunteers: males weighing ≥50kg, females weighing ≥45kg, and body mass index \[BMI = weight (kg)/height 2 (m2)\] within the range of 19.0 \ 26.0kg/m2 (including borderline values); patients with prostate cancer: patients with pathologically-confirmed biochemical relapsed or primary diagnosed prostate cancer with highly suspected systemic metastases on conventional imaging or PSA levels; patients with neuroendocrine tumour patients: patients with NET (G2-G3) or NEC confirmed by pathology and highly suspected of having more than 3 metastases by conventional imaging; patients with glioma: patients with glioma confirmed by pathology or highly suspected by enhanced MRI and proposed to undergo surgical resection; patients with Parkinson's syndrome: patients with high clinical suspicion of Parkinson's syndrome. Subjects can fully understand and voluntarily participate in this experiment and sign an informed consent form.
Exclusion criteria
* Those who cannot tolerate intravenous drug delivery methods (e.g., history of needle and blood sickness); those with alcohol allergy; and those who, in the opinion of the investigator, are unsuitable to undergo or are unable to complete imaging studies such as PET for specific reasons; Under 18 years of age or ECOG score \> 2; Less than 1 month after completion of radiotherapy and less than 2 months after completion of octreotide treatment in patients with neuroendocrine tumours; Women during pregnancy and breastfeeding; Practitioners requiring prolonged exposure to radioactive conditions; Serious diseases of heart, kidney, lung, vascular, nervous and mental systems, immunodeficiency diseases and hepatitis/cirrhosis; Participation in other interventional clinical trials within 1 month prior to screening; Presence of other conditions that, in the opinion of the investigator, make participation in this study unsuitable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance | 1 day from injection of the tracer | calculated by using the 68Ga, 11C and 18F individual imaging images as the gold standard, and calculating the signal clearance of the lesion area on the 18F/68Ga and 18F/11C separate images |
| Signal retention | 1 day from injection of the tracer | using the 68Ga, 11C, 18F individual imaging images as the gold standard and calculating the retention of the letter lesion area number on the 68Ga/18F and 11C/18F separate images |
| SUVmax difference values | 1 day from injection of the tracer | paired t-test comparing the difference in SUVmax values of lesions on gold standard versus 68Ga/18F and 11C/18F separation images |
Countries
China
Contacts
Primary ContactYing Guo Ying Guo
Outcome results
None listed