Clinical trial NCT06914427: PET/CT Imaging Study With Simultaneous Dual-nuclide Imaging Technique
Official title: PET/CT Imaging Study With Simultaneous Dual-nuclide Imaging Technique
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostatic Neoplasms
Glioma
PARKINSON DISEASE (Disorder)
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Signal retention
timeFrame: 1 day from injection of the tracer
measure: Clearance
timeFrame: 1 day from injection of the tracer
measure: SUVmax difference values
timeFrame: 1 day from injection of the tracer
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
References: