Safety Study of 89Zr-NY001 PET Imaging in Patients | NCT04971369

Studies
Safety Study of 89Zr-NY001 PET Imaging in Patients

NCT04971369

Sponsor

Wuxi No. 4 People's Hospital

Status

Unknown status

Last Update Posted

Jul 27, 2021Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Solid Tumor, Adult

Interventions

89Zr-NY001

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Estimated

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Jul 20, 2021

First Submission Date that Met QC Criteria

Jul 20, 2021

First Posted Date

Jul 21, 2021Actual

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

Jul 23, 2021

Last Update Posted Date

Jul 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY001 (89Zr-NY001) PET imaging in patients with fibronectin ED-B domain positive solid tumors.

Detailed Description

After being fully informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of 89Zr-NY001 and will undergo PET/CT scanning to determine uptake of 89Zr-NY001 in tumor lesions and the whole body.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
89Zr-NY001 injection	Experimental	Patients will receive a tracer (5 mg, IV) dose of Zr-89 (1.5-2 mCi) labeled NY001 (89Zr-NY001)	Diagnostic Test: 89Zr-NY001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
89Zr-NY001	Diagnostic Test	89Zr-NY001 injection followed by 89Zr-NY001 PET scan	89Zr-NY001 injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Focal lesion of 89Zr-NY001 PET scanning in patients with fibronectin ED-B domain positive solid tumors.	Degree and localization of focal lesion compared with that of 18F-FDG PET scans and according to the expression of fibronectin ED-B domain will be reported.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients voluntarily signed informed consent;
Aged >18, male or female;
Patients diagnosed with solid tumors confirmed by histopathology or cytology test;
At least two measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
Patients with biopsy-proven fibronectin ED-B positive;
ECOG score ≤ 0~3; Life expectancy of at least 3 months;
Women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects;
ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit;
Other routine examinations are within the normal range or considered acceptable by the researchers.

Exclusion Criteria:

Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
Patients with systemic or locally severe infections, or other serious coexisting diseases;
Patients with allergies or allergies to any component of the imaging agent or antibody;
Patients who cannot perform PET/CT imaging scan;
Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
Patients with autoimmune diseases, including rheumatoid arthritis;
Inadequate control of arrhythmias, including atrial fibrillation;
Uncontrolled hypertension;
Syphilis, HBV, HCV, or HIV positive subjects;
Male and female subjects of reproductive age cannot take effective contraceptive measures;
Pregnant or lactating women;
Patients with a history of mental illness or related conditions;
Other subjects considered unsuitable by researchers.

Accepts Healthy Volunteers

Sex

All

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