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Trial Title:
99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer
NCT ID:
NCT06419348
Condition:
Prostate Cancer Stage
PSMA
SPECT
Conditions: Official terms:
Prostatic Neoplasms
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:
99mTc-QULIC-5-P1
Description:
Each subject receives a single intravenous injection of 99mTc-QULIC-5-P1.
Arm group label:
99mTc-QULIC-5-P1
Summary:
99mTc-QULIC-5-P1 is a new radiotracer targeting PSMA, which is promising as an excellent
imaging agent applicable to PSMA positive prostate cancer. This study will investigate
the safety, biodistribution and potential usefulness of 99mTc-QULIC-5-P1 SPECT imaging
for the diagnosis of lesions in PSMA positive prostate cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. At least 18 years of age.
2. Signed informed consent.
3. Patients with suspected or newly diagnosed or previously prostate cancer, with PSMA
positive expression (supporting evidence may include MRI, CT, and pathology report,
etc).
Exclusion Criteria:
1. Patients with PSMA negative expression.
2. Patients with pregnancy.
3. The inability or unwillingness of the research participant, parent or legal
representative to provide written informed consent.
4. Known or expected hypersensitivity to 99mTc-QULIC-5-P1 or any of its components.
5. Any serious medical condition or extenuating circumstance which the investigator
feels may interfere with the procedures or evaluations of the study.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400016
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoyang Zhang, PhD
Phone:
023-89011755
Email:
zhangxy@mail.bnu.edu.cn
Start date:
May 20, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
First Affiliated Hospital of Chongqing Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Chongqing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06419348
