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NCT Number: NCT06914427

PET/CT Imaging Study With Simultaneous Dual-nuclide Imaging Technique

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET/CT

Diagnostic Test

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.

Primary outcomes

  1. Signal retention

    Time frame: 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

  2. Clearance

    Time frame: 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

  3. SUVmax difference values

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Guo Ying Guo

CONTACT

[email protected]

0086+15991459177

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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