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Trial Title:
Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis
NCT ID:
NCT05955677
Condition:
Prostate Cancer
PET/CT
Conditions: Official terms:
Prostatic Neoplasms
Recurrence
Gallium 68 PSMA-11
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[68Ga]Ga-PSMA-D5
Description:
Each subject receive a single intravenous injection of [68Ga]Ga-PSMA-D5, and undergo
PET/CT imaging within the specificed time.
Arm group label:
[68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan
Other name:
[68Ga]Ga-PSMA-D5 injection
Intervention type:
Drug
Intervention name:
[68Ga]Ga-PSMA-11
Description:
Each subject receive a single intravenous injection of [68Ga]Ga-PSMA-11, and undergo
PET/CT imaging within the specificed time.
Arm group label:
[68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan
Other name:
[68Ga]Ga-PSMA-11 injection
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiang Xie, MD
Phone:
+8613721108043
Email:
xieqiang1980@ustc.edu.cn
Start date:
July 10, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05955677
