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

NCT ID: NCT06914427

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-28
• Study Completion Date: 2027-03-01

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.

Conditions

Prostatic Neoplasms; Glioma; PARKINSON DISEASE (Disorder)

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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/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.

Group Type: EXPERIMENTAL

PET/CT

Intervention Type: 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.

Interventions

PET/CT

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Ying Guo Ying Guo

Role: CONTACT

guoying01192022@163.com

0086+15991459177

Facility Contacts

Ying Guo Ying Guo

Role: primary

guoying01192022@163.com

0086+15991459177

Other Identifiers

KY20252098-C-1

Identifier Type: -

Identifier Source: org_study_id