Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis

NCT05955677 | Unknown Early Phase 1

• 1 other identifier: First D5
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; PET/CT

Outcome Measures

Primary Outcomes (1)

• Standard uptake value(SUV)

  Standard uptake value(SUV) of \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11 for each target lesion of subjects.

  30 days

Secondary Outcomes (2)

• Diagnostic efficacy

  30 days

• Number of lesions

  30 days

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: [68Ga]Ga-PSMA-D5; Drug: [68Ga]Ga-PSMA-11

Interventions

[68Ga]Ga-PSMA-D5 DRUG

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

Also known as: [68Ga]Ga-PSMA-D5 injection

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

[68Ga]Ga-PSMA-11 DRUG

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

Also known as: [68Ga]Ga-PSMA-11 injection

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

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

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Qiang Xie

  The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

  STUDY CHAIR

Central Study Contacts

Qiang Xie, MD

CONTACT

+8613721108043; xieqiang1980@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 21, 2023
• Study Start: July 10, 2023
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)