99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate... | NCT06419348

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

NCT06419348

Sponsor

First Affiliated Hospital of Chongqing Medical University

Status

Recruiting

Last Update Posted

Jun 4, 2025Actual

Enrollment

30Estimated

Phase

Early Phase 1

Conditions

Prostate Cancer Stage
PSMA
SPECT

Interventions

99mTc-QULIC-5-P1

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2024Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

May 14, 2024

First Submission Date that Met QC Criteria

May 14, 2024

First Posted Date

May 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2025

Last Update Posted Date

Jun 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaoyang Zhang, Principal Investigator, First Affiliated Hospital of Chongqing Medical UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Chongqing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
99mTc-QULIC-5-P1	Experimental	Patients will receive a single administration of 99mTc-QULIC-5-P1	Drug: 99mTc-QULIC-5-P1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
99mTc-QULIC-5-P1	Drug	Each subject receives a single intravenous injection of 99mTc-QULIC-5-P1.	99mTc-QULIC-5-P1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic efficacy	The sensitivity, specificity, and accuracy of 99mTc-QULIC-5-P1 SPECT	15 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 18 years of age.
Signed informed consent.
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:

Patients with PSMA negative expression.
Patients with pregnancy.
The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Known or expected hypersensitivity to 99mTc-QULIC-5-P1 or any of its components.
Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaoyang Zhang, PhD	Contact	023-89011755		zhangxy@mail.bnu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Chongqing Medical University	Recruiting	Chongqing	Chongqing Municipality	400016	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided