Application of the CD73-Targeted Probe ⁶⁸Ga-DOTA-mPNE PET/CT Imaging in the Diagnosis of Malignant Tumors

Not Applicable

Not yet recruiting

• Conditions: Malignant Neoplasms of Brain

• Registration Number: NCT07023640
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This study aims to perform ⁶⁸Ga-DOTA-mPNE PET/CT imaging in patients with clinically suspected or confirmed malignant tumors, in order to evaluate tracer uptake in lesions and analyze CD73 expression levels. In a subgroup of up to 10 participants, dynamic PET/CT imaging will be conducted for up to 90 minutes post-injection to assess the tracer's biodistribution and pharmacokinetic properties.Correlation analyses with relevant clinical indicators (such as pathology, immunohistochemistry, and molecular markers) will be carried out to further assess the diagnostic performance and clinical value of ⁶⁸Ga-DOTA-mPNE PET/CT in guiding tumor diagnosis and treatment. This study is expected to provide a novel molecular imaging tool for malignancies and offer clear, intuitive PET/CT-based evidence to support clinical diagnosis, differential diagnosis, and therapeutic decision-making.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study Start: 2025-06-17
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Primary Completion: 2026-06-17
• Study Completion: 2026-06-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age ≥18 years, with an expected survival of ≥12 weeks.
2. No prior radiotherapy or chemotherapy; eligible for surgery or biopsy to obtain pathological diagnosis.
3. At least one measurable target lesion according to RECIST version 1.1 (Response Evaluation Criteria in Solid Tumors).
4. Written informed consent obtained and able to comply with follow-up requirements.

Exclusion Criteria

1. Severe hepatic or renal dysfunction.
2. Women who are planning to conceive, currently pregnant, breastfeeding, or intend to have children during the study period are not eligible. Fertile participants must use effective contraception during the study.
3. Unable to lie flat for 30 minutes.
4. Refusal to participate in this clinical study.
5. Claustrophobia or other psychiatric disorders.
6. Any other condition deemed unsuitable for study participation by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
SUVmax	Time Frame: Day 1 (on the day of PET/CT imaging)	The area of interest was delineated and the SUVmax value was measured by using the post-processing software built into the acquisition machine.