CD73-targeted 68Ga PET/CT imaging to detect malignant brain tumors

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

This imaging test will try to show whether CD73-targeted 68Ga-DOTA-mPNE PET/CT can detect and characterize malignant brain tumors in adults with suspected or confirmed disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07023640 on ClinicalTrials.gov

What this trial studies

Adults with clinically suspected or confirmed malignant brain tumors will receive a single injection of the CD73-targeted radiotracer 68Ga-DOTA-mPNE and undergo PET/CT imaging to measure tracer uptake in target lesions. In a subgroup of up to 10 participants, dynamic PET/CT imaging will be performed for up to 90 minutes after injection to characterize biodistribution and pharmacokinetics. Imaging findings will be correlated with pathology, immunohistochemistry, and molecular markers when tissue is available to determine how tracer uptake relates to CD73 expression. The protocol excludes patients with severe organ dysfunction, pregnancy, or inability to undergo imaging procedures, and requires measurable lesions per RECIST 1.1 and willingness to undergo biopsy or surgery when indicated.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) with suspected or confirmed malignant brain tumors who have at least one measurable lesion, are treatment‑naive to radiotherapy/chemotherapy, and can undergo PET/CT and planned biopsy or surgery.

Not a fit: Patients with severe hepatic or renal dysfunction, pregnant or breastfeeding individuals, those unable to lie flat or with severe claustrophobia, or patients without measurable lesions or unwilling to undergo required procedures are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this method could provide a noninvasive molecular imaging marker of CD73 expression to improve diagnosis, lesion characterization, and help guide treatment decisions for brain malignancies.

How similar studies have performed: CD73-targeted imaging in humans is relatively novel with limited published data, although other 68Ga-labeled PET tracers have previously shown promise for tumor detection and characterization.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Xianzhong Zhang, PhD — Peking Union Medical College Hospital
• Study coordinator: Chenhao Jia, M.D.

Conditions Malignant Neoplasms of Brain