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

NCT07023640 | Recruiting

• 1 other identifier: PUMCH-CD73-3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasms of Brain

Outcome Measures

Primary Outcomes (1)

• SUVmax

  The area of interest was delineated and the SUVmax value was measured by using the post-processing software built into the acquisition machine.

  Time Frame: Day 1 (on the day of PET/CT imaging)

Study Arms (1)

Malignant Neoplasms

EXPERIMENTAL

Diagnostic Test: 68Ga-DOTA-mPNE

Interventions

68Ga-DOTA-mPNE DIAGNOSTIC_TEST

PET/CT examination was performed after intravenous injection of 68GA-DOTA-mPNE tracer

Malignant Neoplasms

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe hepatic or renal dysfunction.
• 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.
• Unable to lie flat for 30 minutes.
• Refusal to participate in this clinical study.
• Claustrophobia or other psychiatric disorders.
• Any other condition deemed unsuitable for study participation by the investigator.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Study Officials

• Xianzhong Zhang, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenhao Jia, M.D.

CONTACT

18548703382; jiachenhao24@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 17, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): June 17, 2026
• Study Completion (Estimated): June 17, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-06

Locations

CN (1)