PET/CT Imaging Study With Simultaneous Dual-nuclide Imaging Technique
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2025
CompletedFirst Submitted
Initial submission to the registry
March 30, 2025
CompletedFirst Posted
Study publicly available on registry
April 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 6, 2025
March 1, 2025
1.9 years
March 30, 2025
March 30, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Signal retention
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
1 day from injection of the tracer
Clearance
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
1 day from injection of the tracer
SUVmax difference values
paired t-test comparing the difference in SUVmax values of lesions on gold standard versus 68Ga/18F and 11C/18F separation images
1 day from injection of the tracer
Study Arms (1)
before-after study in the same patient
EXPERIMENTALApproximately 35 volunteers are planned to be included in this study. The screened subjects will be scanned with a mononuclide 68Ga/11C probe on the first day, a mononuclide 18F probe on the second day, and a dual-nuclide 68Ga/11C+18F probe on the third day, to validate the isolation effect and quantitative accuracy of dual-nuclide synchrotron imaging technology in humans.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2025
First Posted
April 6, 2025
Study Start
March 28, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 6, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share