Nectin-4 Targeting ADC Probe for PET Imaging in Solid Tumors

Sponsor
Peking University Cancer Hospital & Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05322512
Collaborator
(none)
20
1
17

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Nectin-4 is highly expressed in different types of cancer and is involved in various aspects of tumor proliferation, angiogenesis, metastasis, tumor recurrence, and DNA repair. Therefore, the development of nuclear medicine molecular probes targeting Nectin-4 is of great significance for improving the specificity and accuracy of Nectin-4 related cancer diagnosis.

EV (Enfortumab vedotin) is the first and only drug targeting Nectin-4 so far. By exploring the diagnostic efficacy of 124I-EV in tumors with high nectin-4 expression, it will not only provide evidence for the early diagnosis of tumors. At the same time, the Nectin-4 expression in tumors can be used to develop effective and precise treatment for patients.

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 Targeting ADC Probe for PET Imaging in Solid Tumors
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 124I-EV

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

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

Outcome Measures

Primary Outcome Measures

  1. SUV (Standardized Uptake Value) [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 (124I-EV) in 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:
No
Inclusion Criteria:
  1. 18-75 years old, male or female;

  2. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;

  3. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.

  4. Normal heart function;

  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 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.

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

No locations specified.

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:
NCT05322512
Other Study ID Numbers:
  • 2022KT25
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:

Study Results

No Results Posted as of Jul 20, 2022