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

NCT06994078 | Not Yet Recruiting

• 1 other identifier: XLan-0519
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Urothelial Carcinoma; Breast Cancer; Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Visual and standardized uptake values assessment of lesions and biodistribution

  At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting Nectin-4 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or higher stage.

  1 year

Secondary Outcomes (2)

• Radioactivity in the blood and urine samples

  1 year

• Pathological sections of tumour tissue

  1 year

Study Arms (1)

PET imaging targeting Nectin-4 in malignant tumors

EXPERIMENTAL

Determine if targeting Nectin-4 PET is safe and effective method for imaging of malignant tumors.

Drug: 68Ga-NOTA-Nectin-4 antibody fragment

Interventions

68Ga-NOTA-Nectin-4 antibody fragment DRUG

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.

PET imaging targeting Nectin-4 in malignant tumors

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each subject must meet all enrollment criteria to be eligible to participate in the study:
• : The subject or his/her legal representative is able to sign and date the informed consent form;
• : A commitment to comply with the research procedures and to cooperate in the implementation of the full research process;
• : Adult patients or healthy volunteers (aged 18 or above) of either sex;
• : Patients with clinically suspected or confirmed malignant tumors such as urothelial carcinoma, breast cancer and lung carcinoma (supporting evidence includes serum-related tumor markers, imaging data such as ultrasound, CT, MRI, etc., and histological pathology examination, etc.) and in good general condition;
• : Consistent with the results of specific laboratory tests;
• : Females of childbearing potential who have been using contraception for at least one month prior to screening and who are committed to using contraception for the entire study period and until a specified time after the end of the study；
• : Other set entry criteria.

You may not qualify if:

• : Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.);
• : Having other comorbidities;
• : Patients with known hypersensitivity to Nectin-4 antibody fragment developers or synthetic excipients; fasting blood glucose level greater than 11.0 mmol/L prior to 18F-FDG injection；
• : Have a history of comorbid drug use;
• : Patients considered by the investigator to have poor compliance;
• : Patients during pregnancy or lactation;
• : Persons with other factors that make participation in this test inappropriate.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Breast Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xiaoli Lan, PhD

CONTACT

0086-027-83692633; lxl730724@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)