Skip to content

Nectin-4 Targeting ADC Probe for PET Imaging in Solid Tumors

Nectin-4 Targeting ADC Probe for PET Imaging in Solid Tumors

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05322512
Enrollment
20
Registered
2022-04-11
Start date
2024-05-01
Completion date
2025-12-31
Last updated
2023-11-29

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

Conditions

Solid Tumor

Brief summary

To study the normal physiological distribution of the probe 124I-EV in human body and its ability to detect overexpression of Nectin-4 in tumor lesions.

Detailed description

Nectin-4 is highly expressed in different types of cancer and is involved in various aspects of tumor proliferation, angiogenesis, metastasis, tumor recurrence, and DNA repair. Therefore, the development of nuclear medicine molecular probes targeting Nectin-4 is of great significance for improving the specificity and accuracy of Nectin-4 related cancer diagnosis. EV (Enfortumab vedotin) is the first and only drug targeting Nectin-4 so far. By exploring the diagnostic efficacy of 124I-EV in tumors with high nectin-4 expression, it will not only provide evidence for the early diagnosis of tumors. At the same time, the Nectin-4 expression in tumors can be used to develop effective and precise treatment for patients.

Interventions

DRUG18F-FDG

All enrolled participants will be allocated to undergo one 18F-FDG PET/CT scan.

Sponsors

Peking University Cancer Hospital & Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. 18-75 years old, male or female; 2. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging; 3. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent. 4. Normal heart function; 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 the start of 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.

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.

Design outcomes

Primary

MeasureTime frameDescription
SUV (Standardized Uptake Value)2 yearsSUV 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 (124I-EV) in tumor lesions by measuring SUV on PET/CT.

Contacts

Primary ContactZhi Yang, Professor
pekyz@163.com010-88196495
Backup ContactHua Zhu, Professor
zhuhuabch@pku.edu.cn010-88196495

Outcome results

None listed

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