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Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

Sponsor
Peking University Cancer Hospital & Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05321316
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
18
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma
Actual Study Start Date :
May 31, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-N188

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

Drug: 18F-FDG
All study participants will undergo one 18F-FDG PET/CT scan.

Outcome Measures

Primary Outcome Measures

  1. Standardized uptake value（SUV） [2 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing Beijing China 100142

Sponsors and Collaborators

  • Peking University Cancer Hospital & Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hua Zhu, Professor, Peking University Cancer Hospital & Institute
ClinicalTrials.gov Identifier:
NCT05321316
Other Study ID Numbers:
  • 2022KT37
First Posted:
Apr 11, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Fluorodeoxyglucose F18

Study Results

No Results Posted as of Jul 20, 2022