NCT05322512

Brief Summary

To study the normal physiological distribution of the probe 124I-EV in human body and its ability to detect overexpression of Nectin-4 in tumor lesions.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
2.1 years until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

April 3, 2022

Last Update Submit

November 28, 2023

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • SUV (Standardized Uptake Value)

    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 （124I-EV） in tumor lesions by measuring SUV on PET/CT.

    2 years

Study Arms (1)

124I-EV

EXPERIMENTAL

Imaging cohort All enrolled participants will be allocated to undergo three 124I-EV PET/CT scans.

Drug: 18F-FDG

Interventions

18F-FDGDRUG

All enrolled participants will be allocated to undergo one 18F-FDG PET/CT scan.

124I-EV

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old, male or female;
  • 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.
  • Normal heart function;
  • 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 the start of 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.

You may not qualify if:

  • Serious abnormality of liver, kidney and blood;
  • Pregnant patients;
  • Pregnant and lactation women;
  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Central Study Contacts

Zhi Yang, Professor

CONTACT

010-88196495pekyz@163.com

Hua Zhu, Professor

CONTACT

010-88196495zhuhuabch@pku.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 3, 2022

First Posted

April 11, 2022

Study Start

May 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share