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