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RecruitingNCT06914427ClinicalTrials.gov record

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

Prostatic Neoplasms · Glioma · Lung Cancer · Neuroendocrine Tumors

THE QUICK READ

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.
Understand screening

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.

Prepare your questions

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

No results are flagged as posted.

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

Qiqi Yang Qiqi YangCONTACTyangqiqi_1101@163.com0086+18992601101
Official study title

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

A HUMAN NEXT STEP

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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