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Clinical Trial NCT06462508 for Prostate Cancer, PET/CT is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis Early Phase 1 30 Head-to-Head Comparison Novel Treatment

Recruiting
Clinical Trial NCT06462508 is designed to study Diagnostic for Prostate Cancer, PET/CT. It is a Early Phase 1 interventional study that is recruiting, having started on 20 April 2024, with plans to enroll 30 participants. Led by Anhui Provincial Hospital, it is expected to complete by 31 December 2025. The latest data from ClinicalTrials.gov was last updated on 17 June 2024.
Brief Summary
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]F-PSMA-N5 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
\[18F\]F-PSMA-N5 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.
Official Title

Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study

Conditions
Prostate CancerPET/CT
Other Study IDs
  • PSMA PET STUDY -02
NCT ID Number
NCT06462508
Start Date (Actual)
2024-04-20
Last Update Posted
2024-06-17
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Early Phase 1
Status
Recruiting
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental[18F]F-PSMA-N5 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 \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11.
[18F]F-PSMA-N5
Each subject receive a single intravenous injection of \[18F\]F-PSMA-N5, and undergo PET/CT imaging within the specificed time.
[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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Standard uptake value(SUV)
Standard uptake value(SUV) of \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11 for each target lesion of subjects.
30 days
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Diagnostic efficacy
The sensitivity, specificity and accuracy of \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11 PET/CT were calculated.
30 days
Number of lesions
The number of lesions detected by \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11 PET/CT.
30 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
Accepts Healthy Volunteers
Yes
  • 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 \[18F\]F-PSMA-N5 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.

  • 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.
Anhui Provincial Hospital logoAnhui Provincial Hospital
Study Central Contact
Contact: Qiang Xie, MD, +8613721108043, [email protected]
1 Study Locations in 1 Countries

Anhui

The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）, Hefei, Anhui, 230000, China
Qiang Xie, MD, Contact, +8613721108043, [email protected]
Recruiting