Radiolabelled Nectin-4 Targeted LMW Probe PET/CT in Patients With Lung Lesions

NCT06648317 | Recruiting DMC

• 1 other identifier: 2022KT37-ZY01-1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the ability of \[68Ga\]N188 to detect nectin-4 overexpression in patients with lung lesions.

Conditions

Lung Cancer, Non-Small Cell; Lung Infection

Outcome Measures

Primary Outcomes (1)

• Standardized uptake value（SUV）

  SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions. The uptake of the tracer （68Ga-N188） in lung lesions by measuring SUV on PET/CT.

  1 year

Interventions

FDG-PET OTHER

All study participants will undergo 18F-FDG PET/CT scan within 1 week

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with lung lesions

You may qualify if:

• years old, male or female;
• Heart function is normal;
• Normal heart function;
• Estimated survival ≥12 weeks;
• Good follow-up compliance;
• presence of at least one measurable target lesion according to RECIST1.1 criteria;
• Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test;
• Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;
• The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.

You may not qualify if:

• Serious abnormality of liver, kidney and blood;
• Pregnant patients;
• Pregnant and lactation women;
• \) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nan Li, MD

  Peking University Cnacer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Li

CONTACT

+86-13693090647; rainbow6283@sina.com

Xin Zhou, MD

CONTACT

zhouxinbjmu@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 18, 2024
• Study Start: November 21, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)