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89Zr-labeled NY008 PET Imaging in Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05655676
Recruitment Status : Recruiting
First Posted : December 19, 2022
Last Update Posted : December 19, 2022
Sponsor:
Information provided by (Responsible Party):
Chunjing Yu, Affiliated Hospital of Jiangnan University

Study Description
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Brief Summary:
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY008 PET Imaging in patients with multiple myeloma

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: 89Zr-NY008 Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 89Zr-labeled NY008 PET Imaging in Patients
Actual Study Start Date : May 25, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 89Zr-NY008 Drug: 89Zr-NY008
Patients will receive a tracer (5-10mg, IV) dose of 89Zr (2-3mCi) labelled NY008


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of tissue distribution of 89Zr-NY008 [ Time Frame: 7 days ]
    Biodistribution of 89Zr-NY008 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs will be reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Older than 18 years old, male or female;
  2. Patients diagnosed with relapsing or refractory multiple myeloma；
  3. LVEF≥50%；
  4. ECOG score 0~2；

Exclusion Criteria:

  1. Life expectancy of less than 3 months;
  2. Participated in other clinical research within 1 month;
  3. Recovery from major trauma (including surgery) within 28 days prior to study treatment;
  4. Patients with systemic or locally severe infections, or other serious coexisting diseases;
  5. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
  6. Patients with autoimmune diseases, including rheumatoid arthritis;
  7. Inadequate control of arrhythmias, including atrial fibrillation;
  8. Uncontrolled hypertension;
  9. Patients with allergies or allergies to any component of the imaging agent or antibody;
  10. Patients who cannot undergo PET/CT imaging scan;
  11. Syphilis, HBV, HCV, or HIV positive subjects;
  12. Male and female subjects of reproductive age cannot take effective contraceptive measures;
  13. Pregnant or lactating women;
  14. Patients with a history of mental illness or related conditions;
  15. Other subjects considered unsuitable by researchers.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05655676


Contacts
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Contact: Chunjing Yu 15312238622 ycj_wxd1978@163.com

Locations
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China, Jiangsu
Affiliated Hospital of Jiangnan University Recruiting
Wuxi, Jiangsu, China, 214000
Contact: Chunjing Yu    15312238622    ycj_wxd1978@163.com   
Sponsors and Collaborators
Affiliated Hospital of Jiangnan University
More Information
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Responsible Party: Chunjing Yu, Director, Affiliated Hospital of Jiangnan University
ClinicalTrials.gov Identifier: NCT05655676    
Other Study ID Numbers: LS2020001
First Posted: December 19, 2022    Key Record Dates
Last Update Posted: December 19, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases