68Ga-P3 PET/CT Imaging in Malignancy

NCT ID: NCT05887687

Last Updated: 2024-11-07

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

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-20

Study Completion Date

2025-07-31

Brief Summary

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Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.

\[68Ga\]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.

Detailed Description

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Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.\[68Ga\]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.

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]P3

Subjects with suspected or confirmed malignancy will receive an intravenous injection of 68Ga-P3 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]P3

Intervention Type DRUG

68Ga-P3 is injected intravenously with a dose of 0.06-0.08 mCi/kg.

Interventions

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[68Ga]P3

68Ga-P3 is injected intravenously with a dose of 0.06-0.08 mCi/kg.

Intervention Type DRUG

Other Intervention Names

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[68Ga]-P3 PSMA 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

Maximum Eligible Age

75 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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Xing YANG

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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Xing Yang, Dr.

Role: CONTACT

+861083572928

Facility Contacts

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Xing Yang

Role: primary

+861083572928

Other Identifiers

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[68Ga]P3

Identifier Type: -

Identifier Source: org_study_id

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