Dual-nuclide PET/CT imaging to test simultaneous tracer separation in cancer patients and healthy volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses a self-controlled design to compare dual-tracer PET/CT imaging in up to 35 participants, including cancer patients and normal volunteers. The goal is to validate the ability to separate two tracers and quantify their signals during a single imaging session. Participants will undergo PET/CT scans with both tracers, and imaging data will be analyzed for separation performance and quantitative accuracy. The study is conducted at Xijing Hospital with no listed collaborators beyond the lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Qiqi Yang Qiqi Yang
• Email: yangqiqi_1101@163.com
• Phone: 0086+18992601101

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.