Dosimetry and Preliminary Clinical Application Study of a Novel Probe Targeting CD73

Fujian Medical University (FJMU)

Status and phase: Enrolling; Early Phase 1

Conditions: Malignant Tumour

Treatments: Drug: 68Ga-dPNE; Drug: 18F-FDG

Study type: Interventional

Funder types: Other

Identifiers

NCT06995976

FirstAHFujian-CD73

Details and patient eligibility

About

As a new CD73-targeted PET radiotracer, 68Ga-dPNE, is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-dPNE in human volunteers. Furthermover, we conducted a comparative analysis of 68Ga-dPNE and 18F-FDG imaging to assess both the radiation dosimetry and diagnostic efficacy of 68Ga-dPNE.

Full description

The boom in radiopharmaceuticals continues to persist, including their driving effects in the field of immunotherapy. CD73 (ecto-5'-nucleotidase), a key purine metabolic enzyme, catalyzes the conversion of extracellular nucleotides to adenosine, promoting tumor immune evasion and unfavorable clinical outcomes. Notably, CD73 is highly expressed in 74.3% of breast cancer cases, with its prevalence exceeding 45% in liver, gastric, colorectal, and ovarian cancers. As a new CD73-targeted PET radiotracer, 68Ga-dPNE, is promising as an excellent imaging agent applicable to various cancers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-dPNE, and performed a head-to-head comparison with 18F-FDG PET/CT scans in patients with various cancers.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Signed informed consent and be able to follow up.

Exclusion criteria

Pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

68Ga-dPNE PET/CT

Experimental group

Description:

Intravenous injection of 68Ga-dPNE. 68Ga-dPNE PET/CT will be used to detect tumors.

Treatment:

Drug: 68Ga-dPNE

18F-FDG PET/CT

Experimental group

Description:

Intravenous injection of 18F-FDG. 18F-FDG PET/CT will be used to detect tumors.

Treatment:

Drug: 18F-FDG