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Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 in Patients

Sponsor
Peking University Cancer Hospital & Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04422457
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
20.6
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: 68Ga-DX600 PET/CT
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 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
Actual Study Start Date :
Jun 13, 2020
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Mar 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. SUV [2 years]

    The uptake of uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ethics Committee of Peking University Cancer Hospital Beijing Beijing China 100142

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, Associate Professor, Peking University Cancer Hospital & Institute
ClinicalTrials.gov Identifier:
NCT04422457
Other Study ID Numbers:
  • 2020KT62
First Posted:
Jun 9, 2020
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

Study Results

No Results Posted as of Jul 20, 2022