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Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

Primary Purpose

Urothelial Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-FDG
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urothelial Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18-75 years old, male or female;
  2. Heart function is normal;
  3. Normal heart function;
  4. Estimated survival ≥12 weeks;
  5. Good follow-up compliance;
  6. presence of at least one measurable target lesion according to RECIST1.1 criteria;
  7. Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test;
  8. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;
  9. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.

Exclusion Criteria:

  1. Serious abnormality of liver, kidney and blood;
  2. Pregnant patients;
  3. Pregnant and lactation women;

3) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-N188

Arm Description

Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-N188 PET/CT scan.

Outcomes

Primary Outcome Measures

Standardized uptake value（SUV）
SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （68Ga-N188） in urothelial carcinoma tumor lesions by measuring SUV on PET/CT.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2022
Last Updated
July 18, 2022
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05321316
Brief Title
Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma
Official Title
Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the ability of [68Ga]N188 to detect nectin-4 overexpression in patients with urothelial carcinoma, especially in patients with recurrent or advanced bladder cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-N188
Arm Type
Experimental
Arm Description
Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-N188 PET/CT scan.
Intervention Type
Drug
Intervention Name(s)
18F-FDG
Intervention Description
All study participants will undergo one 18F-FDG PET/CT scan.
Primary Outcome Measure Information:
Title
Standardized uptake value（SUV）
Description
SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （68Ga-N188） in urothelial carcinoma tumor lesions by measuring SUV on PET/CT.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-75 years old, male or female; Heart function is normal; Normal heart function; Estimated survival ≥12 weeks; Good follow-up compliance; presence of at least one measurable target lesion according to RECIST1.1 criteria; Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test; Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging; The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent. Exclusion Criteria: Serious abnormality of liver, kidney and blood; Pregnant patients; Pregnant and lactation women; 3) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Yang, Professor
Phone
010-88196495
Email
pekyz@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Zhu, Professor
Phone
010-88196495
Email
zhuhuabch@pku.edu.cn
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunlian Zhou
Email
zhoushunlian@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

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