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NCT Number: NCT07023640

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

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.

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Key information

Conditions

Malignant Neoplasms of Brain

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Chenhao Jia, M.D.

CONTACT

[email protected]

18548703382

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-DOTA-mPNE

Diagnostic Test

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

Primary outcomes

  1. SUVmax

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chenhao Jia, M.D.

CONTACT

[email protected]

18548703382

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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