Clincosm LogoSign in Get a demo

68Ga-P16-093 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Primary Prostate Cancer Patients

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05324332
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
20.5
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prostate-specific membrane antigen (PSMA)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect primary prostate tumor and its metastases, like the most widely studied 68Ga-PSMA-11. This pilot study was evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-11 in the same group of primary prostate cancer patients.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

Prostate cancer (PC) is one of the most common malignancies worldwide in men, with persistently high numbers dying from this disease. Due to low levels of glycolysis in prostate cancer cell, the uses of 18F-FDG PET/CT to detect prostate cancer and its metastases are limited. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga-labeling have been developed. 68Ga-PSMA PET/CT has demonstrated desirable sensitivity and specificity in the detection of prostate cancer lesions, which can find many micro lesions that cannot be identified by CT, MRI and bone scan. 68Ga-P16-093, a novel radiopharmaceutical modified based on 68Ga-PSMA-11, with the urea fragment of a conjugate that employs the HBED-CC chelator for labeling with 68Ga(III). The HBED-based chelating ligand binds the 68Ga3+ ion with high affinity in a pseudo-octahedral N2O4 coordination sphere by its two phenolate O, two amino-acetate carboxylate O, and two amino N donor atoms. This pilot study was prospectively designed to evaluate the diagnostic performance of 68Ga-P16-093 compared with 68Ga-PSMA-11 in the same group of primary prostate cancer patients.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Pilot Comparison of 68Ga-P16-093 and 68Ga-PSMA-11 in the Same Group of Primary Prostate Cancer Patients
Actual Study Start Date :
Apr 15, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-P16-093 and 68Ga-PSMA-11 PET/ CT scan

Patients of Prostate cancer PET/CT imaging: In two consecutive days, each patient underwent whole-body PET/CT scan after intravenous administration of 68Ga-P16-093 and 68Ga-PSMA-11, respectively.

Drug: 68Ga-P16-093
Intravenous injection of 68Ga-P16-093 with the dosage of 1.8-2.2 MBq (0.05-0.06 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of prostate cancer by PET/CT.
Other Names:
  • 68Ga-P16-093 injection

    • Drug: 68Ga-PSMA-11
    Intravenous injection of 68Ga-PSMA-11 with the dosage of 1.8-2.2 MBq (0.05-0.06 mCi)/kg. Tracer doses of 68Ga-PSMA-11 will be used to image lesions of prostate cancer by PET/CT.
    Other Names:
  • 68Ga-PSMA-11 injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tumor detection rate [through study completion, an average of 1 year]

      comparing the number of tumor detected by 68Ga-P16-093 and 68Ga-PSMA-11 PET/CT

    Secondary Outcome Measures

    1. standardized uptake value (SUV) of tumor [through study completion, an average of 1 year]

      comparing the SUVmax of tumor derived from 68Ga-P16-093 and 68Ga-PSMA-11 PET/CT

    Other Outcome Measures

    1. PSMA expression and SUV [through study completion, an average of 1 year]

      Correlation between PSMA immunoreactive score and SUVmax of tumor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • histologically confirmed untreated primary prostate cancer patients;

    • 68Ga-PSMA-11 and 68Ga-P16-093 PET/CT within a week;

    • signed written consent.

    Exclusion Criteria:

    • known allergy against PSMA;

    • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Principal Investigator: Zhaohui Zhu, MD, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05324332
    Other Study ID Numbers:
    • PekingUMCH P16-093
    First Posted:
    Apr 12, 2022
    Last Update Posted:
    Jun 27, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Gallium 68 PSMA-11

    Study Results

    No Results Posted as of Jun 27, 2022