PET/CT Imaging Study With Simultaneous Dual-nuclide Imaging Technique
Prostatic Neoplasms · Glioma · Lung Cancer · Neuroendocrine Tumors
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 75 years
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 35 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
This is a study using a self-control approach and is expected to recruit 35 volunteers, including prostate cancer patients, neuroendocrine tumour patients, glioma patients, lung cancer patients, and normal volunteers, to undergo dual-tracer PET/CT imaging and to validate the separation performance and quantitative accuracy of simultaneous dual-tracer imaging in humans.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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 Lung cancer: patients with lung cancer or suspected recurrent lung cancer.
- 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, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
before-after study in the same patient
Approximately 35 volunteers are planned to be included in this study. The screened subjects will be scanned with a mononuclide 68Ga/124I labeled tracer on the first day, a mononuclide 18F labeled tracer on another day, and a dual-nuclide 68Ga/124I +18F tracers on another day, to validate the separation performance and quantitative accuracy of simultaneous dual-tracer imaging method in humans.
Diagnostic Test: PET/CT
PET/CT DIAGNOSTIC_TEST
Scanning time: acquisition starts 60±10 minutes after 68Ga/18F labeled tracer injection; 124I labeled tracer around 24h after injection; Scanning parameters: whole-body imaging (cranial vault to mid-thigh), routine single-nuclide 3 min/bed; dual-nuclide 5-15min/bed.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Signal retention
Time frame: 1 day from injection of the tracer
using the 68Ga, 124I, 18F individual imaging images as the gold standard and calculating the retention of the letter lesion area number on the 68Ga/18F and 124I/18F separate images
Clearance
Time frame: 1 day from injection of the tracer
calculated by using the 68Ga, 124I and 18F individual imaging images as the gold standard, and calculating the signal clearance of the lesion area on the 18F/68Ga and 18F/124I separate images
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 124I/18F separation images
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical UniversityXi'an, Shaanxi, ChinaRecruiting
Study team and timeline
- Lead sponsor
- Xijing Hospital
- Study start
- Apr 1, 2025 Actual
- Primary completion
- Mar 1, 2027 Estimated
- Study completion
- Mar 1, 2027 Estimated
- First posted
- Apr 6, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
PET/CT Imaging Study With Simultaneous Dual-nuclide Imaging Technique
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026
