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

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2024-12-31

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.

Conditions

Prostate Cancer; PET/CT

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan

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.

Group Type: EXPERIMENTAL

[68Ga]Ga-PSMA-D5

Intervention Type: DRUG

Each subject receive a single intravenous injection of \[68Ga\]Ga-PSMA-D5, and undergo PET/CT imaging within the specificed time.

[68Ga]Ga-PSMA-11

Intervention Type: DRUG

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

Interventions

[68Ga]Ga-PSMA-D5

Each subject receive a single intravenous injection of \[68Ga\]Ga-PSMA-D5, and undergo PET/CT imaging within the specificed time.

Intervention Type: DRUG

[68Ga]Ga-PSMA-11

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

Intervention Type: DRUG

Other Intervention Names

[68Ga]Ga-PSMA-D5 injection; [68Ga]Ga-PSMA-11 injection

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiang Xie

Role: STUDY_CHAIR

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Locations

The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiang Xie, MD

Role: CONTACT

xieqiang1980@ustc.edu.cn

+8613721108043

Facility Contacts

Qiang Xie, MD

Role: primary

xieqiang1980@ustc.edu.cn

+8613721108043

Other Identifiers

First D5

Identifier Type: -

Identifier Source: org_study_id