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Clinical Study on PET Imaging, Distribution and PK of 89Zr-CD147 in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT04841421
Recruitment Status : Not yet recruiting
First Posted : April 12, 2021
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Yue Chen, The Affiliated Hospital Of Southwest Medical University

Brief Summary:
The primary objective of this study is to observe the distribution of 89Zr-CD147 and radiation dosimetry characteristics in patients with solid tumors. The secondary objective is to observe the pharmacokinetic characteristics of 89Zr-CD147 in patients with solid tumors. This study is a single-center, open-lable study, including 89Zr-CD147 1mCi±10%,89Zr-CD147 3mCi±10% and 89Zr-CD147 5mCi±10% dose group. The trial is expected to last for 2 years from the first patient signing the consent form to the end of the trial.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: 89Zr-CD147 Early Phase 1

Detailed Description:
Antibody based positron emission tomography (immuno-PET) imaging is of increasing importance to visualize and characterize tumor lesions. Additionally, it can be used to identify patients who may benefit from a particular therapy and monitor the therapy outcome.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Study on Positron Emission Tomography (PET) Imaging, Distribution and Pharmacokinetics of 89 Zirconium (Zr)-CD147 in Patients With Solid Tumors
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2024

Arm Intervention/treatment
Experimental: 89Zr-CD147 1mCi±10% 10mg dose group
The activity administered was 1mCi±10% and the mass of radiolabeled CD147 was 10 mg.
Drug: 89Zr-CD147
The 89Zr-CD147 is a promising positron emission tomography probe and it is possible to select suitable tumor patients with CD147 expression to benefit from anti-CD147 treatment.

Experimental: 89Zr-CD147 3mCi±10% 10mg dose group
The activity administered was 3mCi±10% and the mass of radiolabeled CD147 was 10 mg.
Drug: 89Zr-CD147
The 89Zr-CD147 is a promising positron emission tomography probe and it is possible to select suitable tumor patients with CD147 expression to benefit from anti-CD147 treatment.

Experimental: 89Zr-CD147 5mCi±10% 10mg dose group
The activity administered was 5mCi±10% and the mass of radiolabeled CD147 was 10 mg.
Drug: 89Zr-CD147
The 89Zr-CD147 is a promising positron emission tomography probe and it is possible to select suitable tumor patients with CD147 expression to benefit from anti-CD147 treatment.




Primary Outcome Measures :
  1. Standardized uptake value (SUV) [ Time Frame: Day 0-7 ]
    Standardized uptake value of tumor

  2. standardized uptake value ratio (SUVR) [ Time Frame: Day 0-7 ]
    The ratio of the standardized uptake value of the tumor or suspected tumor lesion to the standardized uptake value of normal tissue

  3. Radiation dose [ Time Frame: Day 0-7 ]
    Radiation dose of whole body and major tissues / organs of subjects after administration


Secondary Outcome Measures :
  1. Terminal Half Time (T1/2) [ Time Frame: Day 0-7 ]
    Pharmacokinetic parameters

  2. Clearance (CL) [ Time Frame: Day 0-7 ]
    Pharmacokinetic parameters

  3. Peak Plasma Concentration (Cmax) [ Time Frame: Day 0-7 ]
    Pharmacokinetic parameters

  4. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Day 0-7 ]
    Pharmacokinetic parameters

  5. Distribution (dL) [ Time Frame: Day 0-7 ]
    Pharmacokinetic parameters



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be between 18 and 70 years old (including 18 and 70 years old), male or female;
  2. Patients with advanced solid tumors (stage IV): non-small cell lung cancer (NSCLC); Gastric adenocarcinoma; Colorectal adenocarcinoma, etc ;
  3. Patients must have an ECOG performance status of 0-1;
  4. Patients must have a life expectancy ≥ 12 weeks;
  5. Patients must have adequate organ function:

    White blood cell (WBC) count≥4.0x10^9/L or absolute neutrophil count (ANC) ≥1.5 x 10^9/L, Platelets ≥100 x 10^9/L, Hemoglobin≥ 90g/L ; thrombin time or Activated partial thromboplastin time≤1.5ULN; liver and renal function: Total bilirubin≤1.5ULN (upper limit of normal), Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≤2.5ULN or ≤5ULN (subjects with liver metastasis), alkaline phosphatase (ALP)≤ 2.5ULN (if there is bone metastasis or liver metastasis ALP≤4.5ULN). Urea (BUN)≤1.5ULN, creatinine≤1.5ULN;

  6. Patients must have ≥1 measurable lesion according to RECIST1.1 criteria;
  7. For patients who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration.;
  8. Patients must have the ability to understand and sign an approved ICF.

Exclusion Criteria:

  1. There are any of the following conditions, such as brain metastasis (except for asymptomatic primary or metastatic brain tumors that do not need treatment), carcinomatous meningitis, myocardial infarction (within 6 months before enrollment), unstable angina pectoris, or high risk of uncontrollable arrhythmia, coronary artery bypass grafting, cerebrovascular accident (within 6 months before enrollment), congestive heart failure (cardiac function grade III-IV), pulmonary embolism, deep venous thrombosis, Infections that need to be treated with intravenous antibiotics within 2 weeks, and immunosuppressant therapy after organ transplantation;
  2. Primary central nervous system tumor;
  3. HBV DNA≥1000 copies/ml;
  4. HCV-RNA≥1000 copies/ml;
  5. People with positive antibodies to HIV or syphilis;
  6. Patients with acute or subacute intestinal obstruction, or a history of inflammatory bowel disease;
  7. Women who are pregnant, breastfeeding or planning pregnancy;
  8. People who are known to be allergic to the study preparation or its auxiliary materials;
  9. People with a history of psychotropic substance abuse and inability to get rid of it or mental disorders;
  10. Patients who cannot lie for half an hour;
  11. Patients who are allergic to any component of the imaging agent or antibody;
  12. Patients who cannot accept PET/CT imaging;
  13. Situations that other researchers consider unsuitable to participate in the trial.

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): NCT04841421


Contacts
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Contact: Yue Chen, PHD 13700989831 chenyue5523@126.com
Contact: Lin Qiu, PHD 15984011133 qiulin17111210041@163.com

Sponsors and Collaborators
Sinotau Pharmaceutical Group
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Responsible Party: Yue Chen, Director, The Affiliated Hospital Of Southwest Medical University
ClinicalTrials.gov Identifier: NCT04841421    
Other Study ID Numbers: STB017
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
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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Neoplasms