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

NCT ID: NCT05322512

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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124I-EV

Imaging cohort All enrolled participants will be allocated to undergo three 124I-EV PET/CT scans.

Group Type EXPERIMENTAL

18F-FDG

Intervention Type DRUG

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

Interventions

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18F-FDG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Hua Zhu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Zhi Yang, Professor

Role: CONTACT

[email protected]
010-88196495

Hua Zhu, Professor

Role: CONTACT

[email protected]
010-88196495

Other Identifiers

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2022KT25

Identifier Type: -

Identifier Source: org_study_id