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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06995976
Enrollment
30
Registered
2025-05-30
Start date
2025-03-01
Completion date
2026-03-01
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Tumour

Brief summary

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

DRUG68Ga-dPNE

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

DRUG18F-FDG

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

Sponsors

First Affiliated Hospital of Fujian Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
SUV of tumorsThrough study completion, an average of 3 monthsCompare the SUV of tumors between 68Ga-dPNE PET/CT and 18F-FDG PET/CT.

Secondary

MeasureTime frameDescription
Diagnostic valueThrough study completion, an average of 3 monthsSensitivity and specificity of 68Ga-dPNE in patients with various types of cancer and compare it with 18F-FDG PET/CT.

Countries

China

Contacts

Primary ContactWeibing Miao, MD
miaoweibing@126.com+86-0591-87981618
Backup ContactRong Lin, MD
linrong1214@foxmail.com+86-0591-87981619

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026