68Ga-N188 PET/CT Imaging in Malignancy

NCT ID: NCT05593107

Last Updated: 2024-11-21

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

RECRUITING

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-12

Study Completion Date

2025-07-31

Brief Summary

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The Nectin-4 protein belongs to the cell adhesion factors family and has a tissue-specific expression spectrum in normal human tissues. However, Nectin-4 is overexpressed in various malignancies, especially those of epithelial origins, such as uroepithelial carcinoma, making Nectin-4 a highly specific and significant imaging target for malignancies.

\[68Ga\]N188, a novel molecular probe of PET imaging agent that targets Nectin-4, can be used in the diagnosis and research of a wide variety of Nectin-4 high-expression malignancies, including bladder cancer.

Detailed Description

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Conditions

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Neoplasms

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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[68Ga]N188

Subjects with suspected or confirmed malignancy will receive an intravenous injection of 68Ga-N188 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period.

Group Type EXPERIMENTAL

[68Ga]N188

Intervention Type DRUG

68Ga-N188 is injected intravenously with a dose of 0.06-0.08 mCi/kg.

Interventions

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[68Ga]N188

68Ga-N188 is injected intravenously with a dose of 0.06-0.08 mCi/kg.

Intervention Type DRUG

Other Intervention Names

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68Ga-N188 Nectin-4 specific PET imaging

Eligibility Criteria

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Inclusion Criteria

* patients with confirmed or suspected cancer;
* 18F-FDG PET/CT within 1 week;
* Signed written informed consent.

Exclusion Criteria

* Pregnant and lactating women;
* Female patients plan to become pregnant within 6 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jianhua ZHANG

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianhua Zhang, Dr.

Role: CONTACT

+861083572791

Facility Contacts

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Jianhua Zhang

Role: primary

+861083572791

Jianhua Zhang, Dr.

Role: backup

Other Identifiers

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[68Ga]N188

Identifier Type: -

Identifier Source: org_study_id

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