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68Ga-PSMA-11 PET/CT in Patients With Various Types of Cancer

Sponsor
First Affiliated Hospital of Fujian Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04831541
Collaborator
(none)
600
Enrollment
1
Location
1
Arm
38.6
Anticipated Duration (Months)
15.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the potential usefulness of 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions, efficacy assessment and recurrence monitoring in various types of cancer.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

Subjects with various types of cancer underwent 68Ga-PSMA-11 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-PSMA-11 PET/CT were calculated.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
68Ga-PSMA-11 PET/CT in Patients With Various Types of Cancer
Actual Study Start Date :
Oct 10, 2020
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-PSMA-11

Each subject receive a single intravenous injection of 68Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.

Drug: 68Ga-PSMA-11
Each subject receive a single intravenous injection of 68Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.
Other Names:
  • Diagnostic Test: PET/CT scan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Standardized uptake value (SUV) [30 days]

      Standardized uptake value (SUV) of 68Ga-PSMA-11 for each target lesion of subject or suspected primary tumor or/and metastasis.

    Secondary Outcome Measures

    1. Diagnostic efficacy [30 days]

      The sensitivity, specificity and accuracy of 68Ga-PSMA-11 PET/CT were calculated.

    Eligibility Criteria

    Criteria

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

    (i) adult population (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-PSMA-11 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

    Exclusion Criteria:

    (i) patients with pregnancy; (ii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China 350005

    Sponsors and Collaborators

    • First Affiliated Hospital of Fujian Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weibing Miao, PhD, Director, Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
    ClinicalTrials.gov Identifier:
    NCT04831541
    Other Study ID Numbers:
    • FirstAHFujian6
    First Posted:
    Apr 5, 2021
    Last Update Posted:
    Apr 6, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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 Apr 6, 2021