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Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 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: NCT04422457
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hua Zhu, Beijing Cancer Hospital

Brief Summary:

Angiotensin-converting enzyme 2 (ACE2) plays an important role in renin-angiotensin system (RAS) and has been reported to relate with cancer. Recently, it has also been proved as the key target for COVID-19 infection.

DX600 is a polypeptide that can specific binding to ACE2 specifically with nanomolar affinity reported in literature. This study constrcuted a radio-tracer, DX600 Labeled by PET Radionuclide, to monitoring biodistribution ACE2 in human beings, evaluate the detection ability of radio-tracer in ACE2 over-expression tumors and dynamic changes of ACE2 expression under therapy.


Condition or disease Intervention/treatment Phase
Solid Tumor Other: 68Ga-DX600 PET/CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 in Patients
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Imaging cohort
All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-DX600 PET/CT scans
Other: 68Ga-DX600 PET/CT
DX600, labeled with 68Ga will be used as a molecular imaging tracer for PET/CT scanning




Primary Outcome Measures :
  1. SUV [ Time Frame: 2 years ]
    The uptake of uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value(SUV)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-75 years old; both sex;
  • ECoG 0 or 1;
  • Patients that would undergo biopsy or surgical operation with high ACE2 expression tumors such as colorectal cancer, renal cancer, pancreatic cancer, gastric cancer, liver cancer, lung cancer, brain cancer or suspected tumor.
  • use 18F-FDG PET/CT as baseline evaluation

Exclusion Criteria:

  • Significant hepatic or renal dysfunction;
  • Is Pregnant or ready to pregnant;
  • Cannot lie on their back for half an hour;
  • Suffering from claustrophobia or other mental diseases;
  • Refusal to join the clinical study;

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): NCT04422457


Contacts
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Contact: Hua Zhu 010-88196495 zhuhuabch@pku.edu.cn

Sponsors and Collaborators
Beijing Cancer Hospital
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Responsible Party: Hua Zhu, Associate Professor, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT04422457    
Other Study ID Numbers: 2020KT62
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
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