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

NCT06648317 — Recruiting, 20 participants, Peking University Cancer Hospital & Institute

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RegistryNCT06648317
StatusRecruiting
Study typeObservational
Enrollment20 (Estimated)
SponsorPeking University Cancer Hospital & Institute (Other)
ConditionsLung Cancer, Non-Small Cell, Lung Infection
InterventionsFDG-PET (Other)
Datesstart 2024-11-21, primary completion 2025-03-01 (estimated), completion 2025-12-01 (estimated), first posted 2024-10-18, last updated 2024-11-25
Locations1 site in China

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-Summary

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

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+Detailed description

To evaluate the ability of \[68Ga\]N188 to detect nectin-4 overexpression in patients with different lung lesions, such as inflammation and lung cancer.

+Arms and interventions

  • FDG-PET (Other): All study participants will undergo 18F-FDG PET/CT scan within 1 week

+Outcome measures

Primary outcomes

  • Standardized uptake value(SUV) [1 year]: 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.

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

1. 18-75 years old, male or female;
2. Heart function is normal;
3. Normal heart function;
4. Estimated survival ≥12 weeks;
5. Good follow-up compliance;
6. presence of at least one measurable target lesion according to RECIST1.1 criteria;
7. 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;
8. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;
9. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.

Exclusion Criteria:

1. Serious abnormality of liver, kidney and blood;
2. Pregnant patients;
3. Pregnant and lactation women;

3\) 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.

+Locations (1)

FacilityCityCountryStatus
Peking University Cancer Hospital & InstituteBeijing, Beijing MunicipalityChinaRecruiting

+Investigators

  • Nan Li, MD, Principal investigator, Peking University Cnacer Hospital & Institute

My Notes