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Recruiting NCT06995976

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

Early Phase I Interventional Malignant Tumour

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-dPNE, 18F-FDG.
Who it may be relevant to
Registry conditions: Malignant Tumour. Basic parameters: 18 years — 90 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

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.

Detailed 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.

Interventions

  • Drug 68Ga-dPNE
    Intravenous injection of 68Ga-dPNE. 68Ga-dPNE PET/CT will be used to detect tumors.
  • Drug 18F-FDG
    Intravenous injection of 18F-FDG.18F-FDG PET/CT will be used to detect tumors.

Primary outcome measures

  • SUV of tumors [Time frame: Through study completion, an average of 3 months]
Secondary outcome measures (1)
  • Diagnostic value [Time frame: Through study completion, an average of 3 months]

Eligibility criteria

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.

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

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • The First Affiliated Hospital of Fujian Medical University — Fuzhou

Identifiers

NCT: NCT06995976 · FirstAHFujian-CD73

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗