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Recruiting NCT07023640

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

No phase Interventional Malignant Neoplasms of Brain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 68Ga-DOTA-mPNE.
Who it may be relevant to
Registry conditions: Malignant Neoplasms of Brain. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • SUVmax [Time frame: Time Frame: Day 1 (on the day of PET/CT imaging)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT07023640 · PUMCH-CD73-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗