NCT05887687

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

November 7, 2024

Status Verified

October 1, 2024

Enrollment Period

2.2 years

First QC Date

May 24, 2023

Last Update Submit

November 5, 2024

Conditions

Neoplasms

Keywords

[68Ga]P3PSMAPET/CTNeoplasms

Outcome Measures

Primary Outcomes (2)

  • The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors

    Compare the standardized Uptake Value (SUV) of lesions on 68Ga-P3 and 18F-FDG PET/CT

    1 year

  • The detection efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors

    Compare the number of lesions detected by 68Ga-P3 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.

    1 year

Secondary Outcomes (3)

  • The dosimetry of 68Ga-P3

    1 year

  • Quantitative evaluation of 68Ga-P3

    1 year

  • Correlation with pathological expression

    1 year

Study Arms (1)

[68Ga]P3

EXPERIMENTAL

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.

Drug: [68Ga]P3

Interventions

[68Ga]P3DRUG

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

Also known as: [68Ga]-P3, PSMA specific PET imaging
[68Ga]P3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant and lactating women; Female patients plan to become pregnant within 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Xing Yang, Dr.

CONTACT

+861083572928yangxing2017@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 5, 2023

Study Start

May 20, 2023

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

November 7, 2024

Record last verified: 2024-10

Locations

CN(1)