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NeoplasmsNCT05940259

68Ga-P3 PET/CT Imaging in Prostate

A study testing [68Ga]P3 in people with Neoplasms, run by Peking University First Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, men onlyHealthy volunteers can take part
Conditions the study is for
Neoplasms
What is being tested?
[68Ga]P3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
29 May 2023to 31 Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • patients with confirmed or suspected cancer; Signed written informed consent

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xing Yang, Dr. contact

+861083572928

yangxing2017@bjmu.edu.cn

China1 site, 1 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Xing Yang, +861083572928, yangxing2017@bjmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Study to Evaluate 68Ga-P3 PET/CT Imaging of PSMA Expression in Prostate

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.

Read the detailed description

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
Neoplasms
Being tested
[68Ga]P3
Keywords
[68Ga]P3, PSMA, PET/CT, Neoplasms
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [68Ga]P3Drug

    Also called [68Ga]-P3, PSMA specific PET imaging

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

Study groups in NCT05940259
Study groupRoleWhat they receive
[68Ga]P3ExperimentalSubjects with suspected or confirmed Prostate will receive an intravenous injection of 68Ga-P3 followed by PET imaging.
Receives: Drug: [68Ga]P3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate

    the standardized Uptake Value (SUV) of lesions on 68Ga-P3 PET/CT

    Measured: 1 year

  2. The detection efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate

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

    Measured: 1 year

Secondary outcomes (3)

  1. The dosimetry of 68Ga-P3

    Research on the dose distribution of 68Ga-P3 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software

    Measured: 1 year

  2. Quantitative evaluation of 68Ga-P3

    Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens

    Measured: 1 year

  3. Correlation with pathological expression

    Analyze PSMA expression at the imaging level in combination with PSMA expression in pathological specimens

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2023
  2. Study start29 May 2023
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05940259
Sponsor's protocol ID
[68Ga] P3
Status last verified
Oct 2024
First submitted
4 Jul 2023
Last updated
7 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing [68Ga]P3 in people with Neoplasms, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xing Yang, Dr. (+861083572928, yangxing2017@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of Prostate (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05940259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.

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