Back to resultsHead-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis
Primary Purpose
Prostate Cancer, PET/CT
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
[68Ga]Ga-PSMA-D5
[68Ga]Ga-PSMA-11
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria: Aged from 18 to 90 years old; Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.); Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment; simultaneous [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 examinations within two weeks; Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment; Sign informed consent. Exclusion Criteria: Patients who cannot cooperate with the examination; Concurrent malignant tumors; Previous alcohol allergy; Patients with liver and kidney dysfunction; Other circumstances deemed by the investigator to be inappropriate for trial participation.
Sites / Locations
- The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan
Arm Description
Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11.
Outcomes
Primary Outcome Measures
Standard uptake value(SUV)
Standard uptake value(SUV) of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 for each target lesion of subjects.
Secondary Outcome Measures
Diagnostic efficacy
The sensitivity, specificity and accuracy of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/CT were calculated.
Number of lesions
The number of lesions detected by [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/CT.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05955677
Brief Title
Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis
Official Title
Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Provincial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent [68Ga]Ga-PSMA-D5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with [68Ga]Ga-PSMA-11.
Detailed Description
[68Ga]Ga-PSMA-D5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of [68Ga]Ga-PSMA-11 PET/CT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, PET/CT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan
Arm Type
Experimental
Arm Description
Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11.
Intervention Type
Drug
Intervention Name(s)
[68Ga]Ga-PSMA-D5
Other Intervention Name(s)
[68Ga]Ga-PSMA-D5 injection
Intervention Description
Each subject receive a single intravenous injection of [68Ga]Ga-PSMA-D5, and undergo PET/CT imaging within the specificed time.
Intervention Type
Drug
Intervention Name(s)
[68Ga]Ga-PSMA-11
Other Intervention Name(s)
[68Ga]Ga-PSMA-11 injection
Intervention Description
Each subject receive a single intravenous injection of [68Ga]Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.
Primary Outcome Measure Information:
Title
Standard uptake value(SUV)
Description
Standard uptake value(SUV) of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 for each target lesion of subjects.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Diagnostic efficacy
Description
The sensitivity, specificity and accuracy of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/CT were calculated.
Time Frame
30 days
Title
Number of lesions
Description
The number of lesions detected by [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/CT.
Time Frame
30 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged from 18 to 90 years old;
Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
simultaneous [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 examinations within two weeks;
Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
Sign informed consent.
Exclusion Criteria:
Patients who cannot cooperate with the examination;
Concurrent malignant tumors;
Previous alcohol allergy;
Patients with liver and kidney dysfunction;
Other circumstances deemed by the investigator to be inappropriate for trial participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Xie, MD
Phone
+8613721108043
Email
xieqiang1980@ustc.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Xie
Organizational Affiliation
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Xie, MD
Phone
+8613721108043
Email
xieqiang1980@ustc.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis
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