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Clinical Application of PET Imaging Targeting Nectin-4 in Malignant Tumors

NCT06994078 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-05-29

No results posted yet for this study

Summary

This study is a diagnostic study. Patients and healthy volunteers with clinically suspected or confirmed urothelial carcinoma, breast cancer, lung carcinoma and other malignant tumors with high expression of Nectin-4 will be recruited for PET/MR or PET/CT imaging targeting a Nectin-4-specific probe (in the case of \[68Ga\]Ga-NOTA-Nectin-4 antibody fragment) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET imaging in patients with contraindications. General information on the subjects' vital signs, clinical data, blood routine, liver and kidney functions and other biochemical indicators and other imaging data were collected, and histopathology of biopsy or surgical specimens was used as the final diagnostic criterion.

Conditions

Interventions

DRUG

68Ga-NOTA-Nectin-4 antibody fragment

To perform integrated PET/MR or PET/CT visualization of patients with clinically suspected or confirmed urothelial carcinoma, breast cancer, lung carcinoma and other malignant tumors with high Nectin-4 expression and healthy volunteers, using specific positron imaging agents targeting Nectin-4 (taking \[68Ga\]Ga-NOTA-Nectin-4 antibody fragment as an example), to achieve the following purposes: Patients with malignant tumors: for diagnosis and staging of diseases, comparing with the gold standard pathological diagnosis, evaluating diagnostic efficacy, clarifying the presence or absence of lesions, and determining the location and nature of lesions; comparing with \[18F\]FDG PET for accurate staging, evaluating the tumor load, and helping to determine the therapeutic plan. Healthy volunteers: Pharmacokinetic analysis will be performed to clarify the distribution and metabolism of the drug in the body and its safety.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-12-31
Completion
2026-04-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06994078 on ClinicalTrials.gov