99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer

Chongqing Medical University

Status and phase: Enrolling; Early Phase 1

Conditions: SPECT; PSMA; Prostate Cancer Stage

Treatments: Drug: 99mTc-QULIC-5-P1

Study type: Interventional

Funder types: Other

Identifiers

NCT06419348

CYYY-KY-2023-268

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

99mTc-QULIC-5-P1

Experimental group

Description:

Patients will receive a single administration of 99mTc-QULIC-5-P1

Treatment:

Drug: 99mTc-QULIC-5-P1